Accommodating intraocular lens

ABSTRACT

An accommodating intraocular lens to be implanted within the natural capsular bag of a human eye from which the natural lens matrix has been removed through an anterior capsule opening in the bag circumferentially surrounded by an anterior capsular remnant. During a postoperative healing period following surgery, the anterior capsular remnant fuses to the posterior capsule of the bag by fibrosis about haptics on the implanted lens while the ciliary muscle is maintained in its relaxed state by a cycloplegic to prevent dislocation of the lens, and the lens is deflected rearwardly by the fibrosing anterior capsular remnant to a distant vision position against the elastic posterior capsule of the bag in which the posterior capsule is stretched rearwardly. After fibrosis is complete, natural brain-induced contraction and relaxation of the ciliary muscle relaxes and stretches the fibrosed anterior remnant and increases and reduces vitreous pressure in the eye to effect vision accommodation by the remnant, the posterior capsule, and vitreous pressure. A method of utilizing the intraocular lens to provide a patient with vision accommodation.

REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.09/740,679, filed Dec. 19, 2000, which is a continuation of Ser. No.08/987,531, filed Dec. 9, 1997, now U.S. Pat. No. 6,197,059, which is acontinuation-in-part of Ser. No. 08/640,118, filed Apr. 30, 1996, nowabandoned, which is a continuation of Ser. No. 08/500,010 filed Jul. 10,1995, now abandoned, which is a continuation of Ser. No. 08/113,215,filed Aug. 27, 1993, now abandoned, which is a continuation-in-part ofSer. No. 08/020,630, filed Feb. 22, 1993, now U.S. Pat No. 5,476,514,which is a continuation-in-part of Ser. No. 07/915,453, filed Jul. 16,1992, now abandoned, which is a continuation-in-part of Ser. No.07/515,636, filed Apr. 27, 1990, now abandoned.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to intraocular lenses and moreparticularly to novel accommodating intraocular lenses for implantationwithin the capsular bag of a human eye from which the natural lensmatrix has been removed by an extraction procedure which leaves intactwithin the eye the posterior capsule and an anterior capsule remnant ofthe natural lens. The invention relates also to a novel method ofutilizing the intraocular lenses in a human eye to provide the patientwith accommodation capability responsive to normal ciliary muscleaction.

2. Prior Art

The human eye has an anterior chamber between the cornea and the iris, aposterior chamber behind the iris containing a crystalline lens, avitreous chamber behind the lens containing vitreous humor, and a retinaat the rear of the vitreous chamber. The crystalline lens of a normalhuman eye has a lens capsule attached about its periphery to the ciliarymuscle of the eye by zonules and containing a crystalline lens matrix.This lens capsule has elastic optically clear anterior and posteriormembrane-like walls commonly referred by ophtalmologists as anterior andposterior capsules, respectively. Between the iris and ciliary muscle isan annular crevice-like space called the ciliary sulcus.

The human eye possesses natural accommodation capability. Naturalaccommodation involves relaxation and constriction of the ciliary muscleby the brain to provide the eye with near and distant vision. Thisciliary muscle action is automatic and shapes the natural crystallinelens to the appropriate optical configuration for focussing on theretina the light rays entering the eye from the scene being viewed.

The human eye is subject to a variety of disorders which degrade ortotally destroy the ability of the eye to function properly. One of themore common of these disorders involves progressive clouding of thenatural crystalline lens matrix resulting in the formation of what isreferred to as a cataract. It is now common practice to cure a cataractby surgically removing the cataractous human crystalline lens andimplanting an artificial intraocular lens in the eye to replace thenatural lens. The prior art is replete with a vast assortment ofintraocular lenses for this purpose.

Examples of such lenses are described in the following U.S. Pat. Nos.4,254,509, 4,298,996, 4,842,601, 4,963,148, 4,994,082, 5,047,051.

As is evident from the above patents, intraocular lenses differ widelyin their physical appearance and arrangement. This invention isconcerned with intraocular lenses of the kind having a central opticalregion or optic and haptics which extend outward from the optic andengage the interior of the eye in such a way as to support the optic onthe axis of the eye. My above-listed U.S. Pat. No. 5,047,051, disclosesan intraocular lens having a haptic anchor plate, an optic at thelongitudinal center of the plate, and resilient haptic loops staked tothe ends of the plate.

Up until the late 1980's, cataracts were surgically removed by eitherintracapsular extraction involving removal of the entire human lensincluding both its outer lens capsule and its inner crystalline lensmatrix, or by extracapsular extraction involving removal of the anteriorcapsule of the lens and the inner crystalline lens matrix but leavingintact the posterior capsule of the lens. Such intracapsular andextracapsular procedures are prone to certain post-operativecomplications which introduce undesirable risks into their utilization.Among the most serious of these complications are opacification of theposterior capsule following extracapsular lens extraction, intraocularlens decentration, cystoid macular edema, retinal detachment, andastigmatism.

An improved surgical procedure called anterior capsulotomy was developedto alleviate the above and other post-operative complications and risksinvolved in intracapsular and extra-capsular cataract extraction. Simplystated, anterior capsulotomy involves forming an opening in the anteriorcapsule of the natural lens, leaving intact within the eye a capsularbag having an elastic posterior capsule, and anterior capsular remnantor rim about the anterior capsule opening, and an annular sulcus,referred to herein as a capsular bag sulcus, between the anteriorcapsule remnant and the outer circumference of the posterior capsule.This capsular bag remains attached about its periphery to thesurrounding ciliary muscle of the eye by the zonules of the eye. Thecataractous natural lens matrix is extracted from the capsular bagthrough the anterior capsule opening by phacoemulsification andaspiration or in some other way after which an intraocular lens isimplanted within the bag through the opening.

A relatively recent and improved form of anterior capsulotomy known ascapsulorhexis is essentially a continuous tear circular or roundcapsulotomy. A capsulorhexis is performed by tearing the anteriorcapsule of the natural lens capsule along a generally circular tear linesubstantially coaxial with the lens axis and removing the generallycircular portion of the anterior capsule surrounded by the tear line. Acontinuous tear circular capsulotomy or capsulorhexis, if performedproperly, provides a generally circular opening through the anteriorcapsule of the natural lens capsule substantially coaxial with the axisof the eye and surrounded circumferentially by a continuous annularremnant or rim of the anterior capsule having a relatively smooth andcontinuous inner edge bounding the opening. When performing a continoustear circular capsulorhexis, however, the anterior rim is oftenaccidentally torn or sliced or otherwise ruptured, or the inner rim edgeis nicked or sliced in a manner which renders the rim prone to tearingwhen the rim is stressed, as it is during fibrosis as discussed below.

Another anterior capsulotomy procedure, referred to as an envelopecapsulotomy, involves cutting a horizontal incision in the anteriorcapsule of the natural lens capsule, then cutting two vertical incisionsin the anterior capsule intersecting and rising from the horizontalincision, and finally tearing the anterior capsule along a tear linehaving an upper upwardly arching portion which starts at the upperextremity of the vertical incision and continues in a downward verticalportion parallel to the vertical incision which extends downwardly andthen across the second vertical incision. This procedure produces agenerally archway-shaped anterior capsule opening centered on the axisof the eye The opening is bounded at its bottom by the horizontalincision, at one vertical side by the vertical incision, at its oppositevertical side by the second vertical incision of the anterior capsule,and at its upper side by the upper arching portion of the capsule tear.The vertical incision and the adjacent end of the horizontal incisionform a flexible flap at one side of the opening. The vertical tear edgeand the adjacent end of the horizontal incision form a second flap atthe opposite side of the opening.

A third capsulotomy procedure, referred to as a beer can or can openercapsulotomy, involves piercing the anterior capsule of the natural lensat a multiplicity of positions along a circular line substantiallycoaxial with the axis of the eye and then removing the generallycircular portion of the capsule circumferentially surrounded by theline. This procedure produces a generally circular anterior capsuleopening substantially coaxial with the axis of the eye and boundedcircumferentially by an annular remnant or rim of the anterior capsule.The inner edge of this rim has a multiplicity of scallops formed by theedges of the pierced holes in the anterior capsule which render theannular remnant or rim prone to tearing radially when the rim isstressed, as it is during fibrosis as discussed below.

Intraocular lenses also differ with respect to their accommodationcapability, and their placement in the eye. Accommodation is the abilityof an intraocular lens to accommodate, that is to focus the eye for nearand distant vision. My U.S. Pat. No. 5,326,347 and certain of theearlier listed patents describe accommodating intraocular lenses. Othersof the listed patents describe non-accommodating intraocular lenses.Most non-accommodating lenses have single focus optics which focus theeye at a certain fixed distance only and require the wearing of eyeglasses to change the focus. Other non-accommodating lenses have bifocaloptics which image both near and distant objects on the retina of theeye. The brain selects the appropriate image and suppresses the otherimage, so that a bifocal intraocular lens provides both near vision anddistant vision sight without eyeglasses. Bifocal intraocular lenses,however, suffer from the disadvantage that each bifocal image representsonly about 40% of the available light and the remaining 20% of the lightis lost in scatter.

There are four possible placements of an intraocular lens within theeye. These are (a) in the anterior chamber, (b) in the posteriorchamber, (c) in the capsular bag, and (d) in the vitreous chamber.

SUMMARY OF THE INVENTION

According to one of its aspects, this invention provides improvedaccommodating intraocular lenses to be implanted within the capsular bagof a human eye which remains in the eye after removal of the naturalmatrix from the human lens capsule through an anterior capsule openingcreated by an anterior capsulotomy and preferably by a capsulorhexis. Animproved accommodating intraocular lens according to the invention has acentral optic and haptics which extend outward from diametricallyopposite sides of the optic and are movable anteriorly and posteriorlyrelative to the optic. In some described lens embodiments, the hapticsare joined at their inner ends to the optic by hinge-like junctionsreferred to herein as hinges, and the anterior/posterior movement of thehaptics involves pivotal movement of the haptics at these hinges. Inother described embodiments, the haptics are resiliently flexible, andthe anterior/posterior movement of the haptics relative to the opticinvolves resilient flexing or bending of the haptics. In this regard, itis important to note at the outset that the terms “flex”, “flexing”,“flexible”, and the like are used herein in a broad sense to cover bothhinged and resiliently bendable haptics.

Certain of the lens embodiments described herein are referred to assimple plate haptic lenses. These simple plate haptic lenses areintended for use when the capsulotomy procedure utilized in the eyesurgery is properly performed and provides an anterior capsule remnantor rim that is not only completely intact and free of splits, tears, andthe like at the time of lens implantation but is also likely to remainintact during subsequent fibrosis. Other described lens embodiments arereferred to as a plate haptic spring lens. These latter lenses areintended for use in those situations in which the capsulotomy producesan anterior capsular remnant which is not intact or which is not likelyto remain intact during fibrosis. Both types of lenses are designed forimplantation within a capsular bag of the eye in a position wherein thelens optic is aligned on the axis of the eye with the anterior capsuleopening in the bag, and the lens haptics are situated within thecapsular bag sulcus in contact with the sulcus wall. The normallyposterior side of the lens then faces the elastic posterior capsule ofthe bag.

The presently preferred lens embodiments of the invention have roundoptics and haptics joined at their inner ends to opposite edges of theoptic by relatively narrow junctions. These junctions occupy onlyrelatively small diametrically opposite edge portions of the optics andleave unobstructed the remaining major circular edge portions of theoptic between the junctions. In the preferred lenses described herein,these junctions are hinge junctions about which the haptics are movableanteriorly and posteriorly relative to the optic. These flexible orhinged junctions form a bridge between the optic and the plate hapticwhich is fixed in position within the anterior and posterior capsules byfibrosis. The bridges are tapered, the widest end being adjacent to theoptic. This allows the bridge to slide in and out of the pocket formedby the fibrosed anterior capsular rim and the posterior capsule,andenables the optic to move anteriorly when the plate haptics aresubjected to end to end compression.

During a post operative healing period on the order of three weeks,active endodermal cells on the posterior side of the anterior capsularrim cause fusion of the rim to the elastic posterior capsule byfibrosis. Fibrosis occurs about the haptics in such a way that thehaptics are effectively “shrink-wrapped” by the capsular bag and formradial pockets between the anterior rim and the posterior capsule. Thesepockets contain the haptics and act to position and center the lens inthe eye. The anterior capsular rim shrinks during fibrosis. Thisshrinkage combined with shrink-wrapping of the haptics causes endwisecompression of the lens in a manner which tends to deflect the center ofthe lens along the axis of the eye relative to the fixated outer hapticends. The intact fibrosed capsular rim prevents forward deflection ofthe lens, so that fibrosis-induced deflection of the lens occursrearwardly to a position in which the lens presses against the elasticposterior capsule and stretches this capsule rearwardly.

Relaxation of the ciliary muscle during normal use of the eye aftercompletion of fibrosis stretches the capsular bag and the fibrosedanterior capsular rim. The rim is stretched to a taut trampoline-likecondition in which the rim deflects the lens rearwardly to and holds thelens in a posterior position. In this position of the lens, which is itsdistant vision position, the lens optic presses rear-wardly against Andstretches the elastic posterior capsule. The stretched posterior capsulethen exerts a forward bias force on the lens.

The accommodating lenses of the invention are uniquely constructed andarranged to utilize the fibrosed anterior capsular rim, the elasticposterior capsule, the vitreous cavity pressure, and the naturalbrain-controlled ciliary muscle action of the eye to providepostoperative accommodation for near vision. Thus, when looking at anear object, the brain constricts the ciliary muscle. This relaxes thefibrosed anterior rim, increases vitreous cavity pressure, andcompresses the lens endwise in such a way as to effect forwarddeflection, i.e. accommodation movement, of the lens optic along theaxis of the eye to a near vision position. Depending upon the amount ofaccommodation, accommodation deflection of the lens is producedinitially by the increase in vitreous pressure and the forward biasforce of the stretched posterior capsule and finally by forward bucklingof the lens in response to endwise compression of the lens. Subsequentbrain-activated relaxation of the ciliary muscle stretches the capsularbag and the fibrosed anterior capsular rim to return the lens rearwardlytoward its distant vision position.

The preferred lens embodiments of the invention have round optics whichare sized in diameter to pass through the anterior capsule opening.These preferred lenses are constructed and arranged for anterioraccommodation movement of their optics to positions wherein the opticsproject through the anterior capsule opening to maximize theaccommodation range of the lenses.

According to another important aspect of the invention, the ciliarymuscle is paralyzed in its relaxed state at the start of surgery and ismaintained in this relaxed state during both surgery and post-operativefusion of the anterior capsular remnant or rim to the posterior capsuleby fibrosis. The ciliary muscle is thus relaxed by introducing a ciliarymuscle relaxant (i.e. a cycloplegic) into the eye. While variouscycloplegics may be used, the preferred cycloplegic is atropine becauseof its relatively long effective period compared to other cycloplegics.The cycloplegic is initially introduced into the eye at the start ofsurgery to dilate the pupil and paralyze the ciliary muscle in itsrelaxed state. After surgery, cycloplegic drops are periodicallyintroduced into the eye by the patient during a postoperative healingperiod of sufficient duration (normally about two to three weeks) tomaintain the ciliary muscle in its relaxed state until fibrosis iscomplete. This drug-induced relaxation of the ciliary muscle preventscontraction of the muscle and immobilizes the capsular bag duringfibrosis. By this means, the lens is fixed in position within the eyerelative to the retina for distance vision. When the cycloplegic effectwears off and the ciliary muscle can contract again, the contractioncauses end to end compression on the plates thus moving the opticanteriorly for near vision. If the ciliary muscle was not maintained inits relaxed state, the muscle would undergo essentially normalbrain-induced vision accommodation contraction and relaxation duringfibrosis. This ciliary muscle action during fibrosis would not onlyresult in improper formation of the haptic pickets in the fibrosetissue, but also ciliary muscle contraction during fibrosis wouldcompress the capsular bag radially and the lens endwise in such a way asto very likely dislocate the lens from its proper position in the bag.

An accommodating lens according to the invention may have a normalunstressed configuration, such that when deflected from its normalunstressed configuration, the lens develops internal elastic strainenergy forces which bias the lens toward its normal unstressedconfiguration in a manner which aids accommodation. The lens may begenerally flat, anteriorly arched, or posteriorly arched in this normalunstressed configuration. One disclosed embodiment of the lens includesauxiliary springs for aiding lens accommodation. Some disclosed lensembodiments have integral fixation means at the haptic ends around whichfibrosis of the anterior rim of the capsular bag occurs to fix the lensagainst dislocation in the eye. Other disclosed embodiments havefixation elements from which the lens proper is separable to permitlater removal of the lens for repair or correction and replacement ofthe lens in its exact original position within the eye.

As noted earlier, the simple plate haptic lens of the invention isdesigned for use when the anterior capsulotomy performed on the eyeprovides an anterior capsular remnant or rim that remains intact andcircumferentially continuous throughout fibrosis. The plate hapticspring lenses are designed for use when the anterior capsular remnant orrim of the capsular bag is ruptured, that is cut or torn, or is liableto become so during fibrosis. A ruptured capsular rim may be produced indifferent ways. For example, improper performance of a continuous tearcircular capsulotomy, or capsulorhexis, may result in accidental cuttingor tearing of the anterior rim. A beer can or can opener capsulotomy, onthe other hand, produces an anterior capsular rim which is not intactand has an inner scalloped edge having stress-inducing regions thatrender the rim very prone to tearing during surgery or subsequentfibrosis. An envelope capsulotomy inherently produces an anteriorcapsular remnant which is ruptured and not intact.

A ruptured anterior capsular remnant or rim may preclude utilization ofa simple plate haptic lens of the invention for the following reasons. Aruptured rim may not firmly retain the lens haptics in the sulcus of thecapsular bag during fibrosis, thereby rendering the lens prone todecentration and/or posterior or anterior dislocation. A rupturedcapsular rim may be incapable of assuming the taut trampoline-likecondition of a non-ruptured rim. If so, a ruptured capsular rim isincapable of effecting full posterior deflection of a plate haptic lensto a distant viewing position against the posterior capsule during andafter fibrosis. In fact, a ruptured capsular rim may permit anteriordeflection of the lens. In either case, since the power of the lens isselected for each individual patient and is dependent upon theirspectacle power, and since good vision without glasses requires the lensoptic to be at precisely the correct distance from the retina, a simpleplate haptic lens of the invention may not be acceptable for use with aruptured anterior capsular remnant or rim.

The accommodating plate haptic spring lenses of the invention aredesigned for use when the anterior capsular remnant or rim of thecapsular bag is ruptured. These plate haptic spring lenses are similarto the simple plate haptic lenses but have resilient springs, such asspring loops, at the ends of the plate haptics. When a plate hapticspring lens is implanted in a capsular bag, the haptic springs pressoutward against the wall of the capsular bag sulcus to fixate the lensin the bag during fibrosis. Fibrosis occurs about the springs in such away as to effect fusion of the ruptured anterior remnant to theposterior capsule, firm fixation of the springs and hence the haptics inthe bag, and posterior deflection of the lenses against the elasticposterior capsule during fibrosis. Brain-induced constriction andrelaxation of the ciliary muscle after fibrosis with a ruptured capsularrim effects accommodation of the plate haptic spring lens in much thesame way as occurs with the simple plate haptic lens and an intactnon-ruptured capsular rim.

While the plate haptic spring lenses of the invention are designed foruse with a ruptured anterior capsular remnant or rim, these lenses canalso be utilized with an intact rim. A plate haptic spring lens alsocompensates for improper lens placement in the eye with one end of thelens situated in the capsular bag and the other end of the lens situatedin the ciliary sulcus of the eye. In this regard, an advantage of theplate haptic spring lenses of the invention over the simple plate hapticlenses resides in the fact that the spring lenses eliminate the need tohave on hand in the operating room both a simple plate haptic lens foruse with an intact capsular rim and a plate haptic spring lens as asubstitute for the plate haptic lens in the event the rim is rupturedduring surgery.

Another advantage of the plate haptic spring lenses over the simpleplate haptic lenses of the invention resides in the fact that the hapticspring lenses permit an optic of larger diameter than those of simpleplate haptic lenses whose optic diameters will normally be restricted tothe range of 4-7 mm. Thus, the haptic spring lenses rely on the hapticsprings rather than the capsular remnant or rim to retain the lenses inposition during fibrosis. As a consequence, these lenses may be usedwith a capsular remnant or rim of reduced radial width or a capsular rimwhich is slit or torn, both of which rim types provide an anteriorcapsule opening of larger effective size than those possible with asimple plate haptic lens. A larger anterior capsule opening, in turn,permits a larger optic diameter which offers certain opthalmologicalbenefits. According to one aspect of this invention, such a largeopening is provided after fibrosis is complete by using a laser to slitthe anterior capsular rim radially or cut the rim circumferentially toenlarge the opening.

A further aspect of the invention concerns a novel method of utilizingan accommodating lens of the invention to provide accommodation in ahuman eye whose natural lens matrix has been removed from the lenscapsule by a procedure involving anterior capsulotomy of the naturallens. The method may be utilized to replace a natural lens from which acataract has been removed and to correct a refractive error in the eyeof a patient who previously wore glasses in order to enable the patientto see well without glasses. For example, the invention can can beutilized to correct refractive errors and restore accommodation topersons in their mid-40's who require reading glasses or bifocals fornear vision by replacing the clear non-cataractous crystalline lensmatrix of their eyes with an accomodating intraocular lens according tothe invention. According to the method of utilizing a plate hapticspring lens of the invention, the anterior capsular remnant or rim ofthe capsular bag is slit radially or cut to enlarge the anterior capsuleopening after fibrosis is complete to permit the use of a lens with arelatively large diameter optic larger than 6 or 7 mm.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a section through a human eye from which the natural lensmatrix has been removed by a surgical procedure involving anteriorcapsulotomy, such as capsulorhexis, of the natural lens, andillustrating an accommodating simple plate haptic accommodating lensaccording to this invention implanted within the capsular bag of theeye;

FIG. 1A is a section through a normal human eye;

FIG. 2 is an anterior side view of the intraocular lens of FIG. 1;

FIG. 3 is a section taken on line 3—3 in FIG. 2;

FIG. 4 is a section taken on line 4—4 in FIG. 1 FIGS. 5-8 illustrate themanner in which the intraocular lens of FIGS. 1-4 is utilized in the eyeof FIG. 1 to provide accommodation;

FIGS. 9-12 are sections, similar to FIG. 3, through modifiedaccommodating intraocular lenses according to the invention havingalternative optical shapes;

FIG. 13 is a section similar to FIG. 3 through a modified accommodatingintraocular lens according to the invention illustrating the lens in itsnormal unstressed configuration;

FIG. 14 is a section similar to FIG. 13, illustrating the lens in itsdistant vision position;

FIG. 15 is a section through a modified accommodating intraocular lensaccording to the invention having an anteriorly displaced optic;

FIG. 16 is an anterior side view of a modified accommodating intraocularlens according to the invention having integral fixation means forfixing the lens in the capsular bag of the eye;

FIG. 17 is a section taken on line 17—17 in FIG. 16;

FIGS. 18-21 are anterior side views of modified accommodatingintraocular lenses according to the invention having alternativeintegral fixation means for fixing the lenses in the capsular bag of theeye;

FIG. 22 is an anterior side view of a modified accommodating intraocularlens according to the invention having springs for aiding accommodation;

FIG. 23 illustrates the lens of FIG. 22 implanted within the capsularbag of a human eye like that in FIG. 1, and showing the lens in theposition which the lens occupies immediately after surgery as well asafter a certain degree of accommodation;

FIG. 24 is a view similar to FIG. 23 showing the lens in its posteriordistant vision position;

FIGS. 25-30 are anterior side views of modified accommodatingintraocular lenses according to the invention having separate fixationmeans for fixing the lenses in the capsular bag of a human eye like thatin FIG. 1;

FIGS. 31-34 illustrate modified accommodating intraocular lensesaccording to the invention having integral fixation means;

FIGS. 35-37 illustrate the capsulotomy produced by a continuous tearcircular capsulotomy (capsulorhexis), a beer can capsulotomy, and anenvelope capsulotomy, respectively;

FIG. 38 is an anterior face view of a plate haptic spring lens accordingto the invention;

FIG. 39 is a view similar to FIG. 4 showing the plate haptic spring lensof FIG. 38 implanted within the eye;

FIG. 40 is an enlarged section taken on line 40—40 in FIG. 39;

FIGS. 41 and 42 illustrate two ways of enlarging the capsulotomy of acapsular bag after completion of fibrosis to allow anterior movement ofa relatively large lens optic;

FIG. 43 is an anterior side view of a modified plate haptic lensaccording to the invention;

FIGS. 44-46 illustrate modified plate haptic spring lenses according tothe invention;

FIG. 47 is a plan view of the anterior side of a presently referredaccommodating lens according to the invention;

FIG. 48 is a section taken on line 48—48 in FIG. 47;

FIG. 49 illustrates the lens of FIG. 47 implanted within the capsularbag of an eye and shows the lens in its posterior distant visionposition;

FIG. 50 is a view similar to FIG. 49 showing the lens at or near theforward limit of its accommodation;

FIG. 51 is a section similar to FIG. 48 through a modified accommodatinglens according to the invention;

FIG. 52 is a view similar to FIG. 47 of a further modified accommodatinglens according to the invention;

FIG. 53 is a view similar to FIG. 47 of yet a further modifiedaccommodating lens according to the invention

FIG. 54 is a view showing an anteriorly biased accommodating intraocularlens of the invention in its posterior distant vision position withinthe eye after completion of fibrosis following surgery;

FIG. 55 is an enlargement of the area encircled by the arrow 55—55 inFIG. 54;

FIG. 56 is a further enlarged view of an intraocular lens according tothe invention and natural capsular bag, showing incoming light raysfocused on the retina of the eye;

FIGS. 57 and 58 are sectional views showing a preferred anteriorlybiased accommodating intraocular lens according to the invention, whichprovides increased accommodation amplitude and increased diopters ofaccommodation, FIG. 58 showing the preferred intraocular lens in solidlines in a mid-range position of accommodation, in phantom lines in itsposterior distant vision position of accommodation, and in dashed linesin its anterior near vision position of accommodation;

FIG. 59 is an edge view of the lens in FIG. 58;

FIG. 60 is an exploded fragmentary perspective view of a modifiedaccommodating intraocular lens according to the invention havingpivotally hinged haptics;

FIG. 61 is a view similar to FIG. 60 but showing a modified haptic hingearrangement including reinforcing hinge inserts, and a modified hingearrangement;

FIGS. 62 and 63 are views similar to the anterior portion of FIG. 56 butillustrating two modified anteriorly biased accommodating intraocularlenses according to the invention in their posterior distant visionpositions within the capsular bag of the eye;

FIG. 64 is a plan view of an improved accommodating intraocular lensaccording to the invention having extended haptic portions in the formof resiliently bendable fingers defined by haptic inlays;

FIG. 65 illustrates an embodiment similar to that of FIG. 64 andincluding a depressed pocket defined in a haptic for accommodating adrug;

FIG. 65A is a sectional view taken at line 65A—65A in FIG. 65;

FIG. 66 is a plan view of another embodiment of the invention whereinpairs of haptics extend oppositely from an optic, a loop extendsoutwardly between each pair of haptics, and an arm extends generallytransversely of each loop with an end protuberance defining an opening;

FIG. 66A is a sectional view taken at line 66A—66A in FIG. 66; and

FIG. 67 shows another embodiment of the invention wherein haptics extendin spaced relation radially from an optic, and two loops extendoutwardly between respective pairs of haptics, with an arm extendinggenerally transversely of the loops and having protuberances withopenings at their outer ends.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to these drawings and first to FIGS. 1 and 1A, there isillustrated a human eye 10 from which the natural crystalline lensmatrix was previously removed by a surgical procedure involving ananterior capsulotomy, in this case a continuous tear circular tearcapsulotomy, or capsulorhexis. The natural lens comprises a lens capsulehaving elastic anterior and posterior walls A and P, respectively, whichare referred to by ophthalmologists and herein as anterior and posteriorcapsules, respectively. The natural lens capsule (FIG. 1A) contains anormally optically clear crystalline lens matrix M. In many individuals,this lens matrix becomes cloudy with advancing age and forms what iscalled a cataract. It is now common practice to restore a cataractpatient's vision by removing the cataract from the natural lens andreplacing the lens matrix by an artificial intraocular lens.

As mentioned earlier, continous tear circular capsulotomy, orcapsulorhexis, involves tearing the anterior capsule A along a generallycircular tear line in such a way as to form a relatively smooth-edgedcircular opening in the center of the anterior capsule. The cataract isremoved from the natural lens capsule through this opening. Aftercompletion of this surgical procedure, the eye includes an opticallyclear anterior cornea 12, an opaque sclera 14 on the inner side of whichis the retina 16 of the eye, an iris 18, a capsular bag 20 behind theiris, and a vitreous cavity 21 behind the capsular bag filled with thegel-like vitreous humor. The capsular bag 20 is the structure of thenatural lens of the eye which remains intact within the eye after thecontinous tear circular tear capsulorhexis has been performed and thenatural lens matrix has been removed from on the natural lens.

The capsular bag 20 includes an annular anterior capsular remnant or rim22 and an elastic posterior capsule 24 which are joined along theperimeter of the bag to form an annular crevice-like capsular bag sulcus25 between rim and posterior capsule. The capsular rim 22 is the remnantof the anterior capsule of the natural lens which remains aftercapsulorhexis has been performed on the natural lens. This rimcircumferentially surrounds a central, generally round anterior opening26 (capsulotomy) in the capsular bag through which the natural lensmatrix was previously removed from the natural lens. The capsular bag 20is secured about its perimeter to the ciliary muscle of the eye byzonules 30.

Natural accommodation in a normal human eye having a normal humancrystalline lens involves automatic contraction or constriction andrelaxation of the ciliary muscle of the eye by the brain in response tolooking at objects at different distances. Ciliary muscle relaxation,which is the normal state of the muscle, shapes the human crystallinelens for distant vision. Ciliary muscle contraction shapes the humancrystalline lens for near vision. The brain-induced change from distantvision to near vision is referred to as accommodation.

Implanted within the capsular bag 20 of the eye 10 is an accommodatingintraocular lens 32 according to this invention which replaces andperforms the accommodation function of the removed human crystallinelens. Lens 32 is referred to in places as a simple plate haptic lens todistinguish it from the later described plate haptic spring lens of theinvention. As mentioned earlier and will become readily understood asthe description proceeds, the accommodating intraocular lens may beutilized to replace either a natural lens which is virtually totallydefective, such as a cataractous natural lens, or a natural lens thatprovides satisfactory vision at one distance without the wearing ofglasses but provides satisfactory vision at another distance only whenglasses are worn. For example, the accommodating intraocular lens of theinvention can be utilized to correct refractive errors and restoreaccommodation for persons in their mid-40's who require readingglassesor bifocals for near vision.

Intraocular lens 32 comprises a body 33 which may be formed ofrelatively hard material, relatively soft flexible semi-rigid material,or a combination of both hard and soft materials. Examples of relativelyhard materials which are suitable for the lens body are methylmethacrylate, polysulfones, and other relatively hard biologically inertoptical materials. Examples of suitable relatively soft materials forthe lens body are silicone, hydrogels, thermolabile materials, and otherflexible semi-rigid biologically inert optical materials.

The lens body 33 has a generally rectangular shape and includes acentral optical zone or optic 34 and plate haptics 36 extending fromdiametrically opposite edges of the optic. The haptics have inner endsjoined to the optic and opposite outer free ends. The haptics 36 aremovable anteriorly and posteriorly relative to the optic 34, that is tosay the outer ends of the haptics are movable anteriorly and posteriorlyrelative to the optic. The particular lens embodiment illustrated isconstructed of a resilient semi-rigid material and has flexible hinges38 which join the inner ends of the haptics to the optic. The hapticsare relatively rigid and are flexible about the hinges anteriorly andposteriorly relative to the optic. These hinges are formed by grooves 40which enter the anterior side of the lens body and extend along theinner ends of the haptics. The haptics 36 are flexible about the hinges38 in the anterior and posterior directions of the optic. The lens has arelatively flat unstressed configuration, illustrated in FIGS. 2 and 3,wherein the haptics 36 and their hinges 38 are disposed in a commonplane transverse to the optic axis of the optic 34. Deformation of thelens from this unstressed configuration by anterior or posteriordeflection of the haptics about their hinges 38 creates in the hingeselastic strain energy forces which bias the lens to its unstressedconfiguration. If the lens is constructed of a relatively hard opticmaterial, it may be necessary to replace the flexible hinges 38 bypivotal hinges of some kind. In a later described lens embodiment of theinvention, the haptic hinges are eliminated, and the haptics are madeflexible throughout their length.

The accommodating intraocular lens 32 is implanted within the capsularbag 20 of the eye 10 in the position shown in FIGS. 1 and 5. Whenimplanting the lens in the bag, the ciliary muscle 28 of the eye ismaintained in its relaxed state in which the muscle stretches thecapsular bag 20 to its maximum diameter. The lens is inserted into thebag through the anterior capsule opening 26 and placed in the positionshown in FIGS. 1 and 4. In this position, the lens optic 34 is alignedon the axis of the eye with the opening 26, the posterior side of thelens faces the elastic posterior capsule 24 of the bag, and the outerends of the lens haptics 36 are situated within the sulcus 25 at theradially outer perimeter of the bag. The overall length of the lenssubstantially equals the inner diameter (10-11 mm) of the stretchedcapsular bag so that the lens fits snugly within the stretched capsularbag with the outer ends of the haptics in contact with the innerperimeter of the bag, as shown. This prevents decentration of the lensand thereby permits the optic 34 to be smaller such that it can moveforward inside the capsular rim during the later describedaccommodation.

During a post-operative healing period on the order of two to threeweeks following surgical implantation of the lens 32 in the capsular bag20, epithelial cells under the anterior capsular rim 22 of the bag causefusion of the rim to the posterior capsule 24 by fibrosis. This fibrosisoccurs around the lens haptics 36 in such a way that the haptics are“shrink-wrapped” by the capsular bag 20, and the haptics form pockets 42in the fibrosed material F (FIGS. 4 and 6-8). These pockets cooperatewith the lens haptics to position and center the lens in the eye. Inorder to insure proper formation of the haptic pockets 42 and preventdislocation of the lens by ciliary muscle contraction during fibrosis,sufficient time must be allowed for fibrosis to occur to completionwithout contraction of the ciliary muscle 28 from its relaxed state.According to an important aspect of this invention, this is accomplishedby introducing a ciliary muscle relaxant (cycloplegic) into the eyebefore surgery to dilate the pupil and paralyze the ciliary muscle inits relaxed state and having the patient periodically administercycloplegic drops into the eye during a post-operative period ofsufficient duration (two to three weeks) to permit fibrosis to proceedto completion without contraction of the ciliary muscle. The cycloplegicmaintains the ciliary muscle 28 in its relaxed state in which thecapsular bag 20 is stretched to its maximum diameter and immobilized,+and the anterior capsular rim 22 is stretched to a taut trampoline-likecondition or position. The rim fibroses from this taut condition. Thecycloplegic passes through the cornea of the eye into the fluid withinthe eye and then enters the ciliary muscle from this fluid. While othercycloplegics may be used, atropine is the preferred cycloplegic becauseof its prolonged paralyzing effect compared to other cycloplegics. Onedrop of atropine, for example may last for two weeks. However, to be onthe safe side, patients may be advised to place one drop of atropine inthe eye every day during the fibrosis period.

The capsular rim 22 shrinks during fibrosis and thereby shrinks thecapsular bag 20 slightly in its radial direction. This shrinkagecombined with shrink wrapping of the lens haptics 36 produces someopposing endwise compression of the lens which tends to buckle or flexthe lens at its hinges 38 and thereby move the lens optic 34 along theaxis of the eye. Unless restrained, this flexing of the lens might occureither forwardly or rearwardly. The taut anterior capsular rim 22 pushesrearwardly against and thereby prevents forward flexing of the lens.This fibrosis-induced compression of the lens is not sufficient tointerfere with proper formation of the haptic pockets in the fibrosedtissue or cause dislocation of the lens. Accordingly, endwisecompression of the lens by fibrosis aided by the rearward thrust of thetaut capsular rim against the lens haptics 36 causes rearward flexing ofthe lens from its initial position of FIGS. 1 and 5 to its position ofFIG. 6. The lens haptics 36 are made sufficiently rigid that they willnot be bent or bowed by the forces of fibrosis. At the conclusion offibrosis, the lens occupies its posterior position of FIG. 6 wherein thelens presses rearwardly against the elastic posterior capsule 24 andstretches this capsule rearwardly. The posterior capsule then exerts aforward elastic bias force on the lens. This posterior position of thelens is its distant vision position.

Ciliary muscle induced flexing of the lens 32 during fibrosis can beresisted or prevented by placing sutures within the hinge grooves 40.Removal of these sutures after completion of fibrosis may beaccomplished by using sutures that are either absorbable in the fluidwithin the eye or by using sutures made of a material, such as nylon,which can be removed by a laser.

Natural accommodation in a normal human eye involves shaping of thenatural crystalline lens by automatic contraction and relaxation of theciliary muscle of the eye by the brain to focus the eye at differentdistances. Ciliary muscle relaxation shapes the natural lens for distantvision. Ciliary muscle contraction shapes the natural lens for nearvision.

The accommodating intraocular lens 32 is uniquely constructed to utilizethis same ciliary muscle action, the fibrosed capsular rim 22, theelastic posterior capsule 24, and the vitreous pressure within thevitreous cavity 21 to effect accommodation movement of the lens optic 34along the optic axis of the eye between its distant vision position ofFIG. 6 to its near vision position of FIG. 8. Thus, when looking at adistant scene, the brain relaxes the ciliary muscles 28. Relaxation ofthe ciliary muscle stretches the capsular bag 20 to its maximum diameterand its fibrosed anterior rim 22 to the taut trampoline-like conditionor position discussed above. The taut rim deflects the lens rearwardlyto its posterior distant vision position of FIG. 6 in which the elasticposterior capsule 24 is stretched rearwardly by the lens and therebyexerts a forward bias force on the lens. When looking at a near scene,such as a book when reading, the brain constricts or contracts theciliary muscle. This ciliary muscle contraction has the three-foldeffect of increasing the vitreous cavity pressure, relaxing the capsularbag 20 and particularly its fibrosed capsular rim 22, and exertingopposing endwise compression forces on the ends of the lens haptics 36with resultant endwise compression of the lens. Relaxation of thecapsular rim permits the rim to flex forwardly and thereby enables thecombined forward bias force exerted on the lens by the rearwardlystretched posterior capsule and the increased vitreous cavity pressureto push the lens forwardly in an initial accommodation movement from theposition of FIG. 6 to the intermediate accommodation position of FIG. 7.

In this intermediate accommodation position, the lens is substantiallyflat, and the ends of the lens haptics and their hinges 38 are disposedsubstantially in a common plane normal to the axis of the eye. Duringthe initial accommodation, the lens arches rearwardly so that endwisecompression of the lens by ciliary muscle contraction produces arearward buckling force on the lens which resists the initialaccommodation. However, the increased vitreous cavity pressure and theforward bias force of the stretched posterior capsule are sufficient toovercome this opposing rearward buckling force and effect forwardaccommodation movement of the lens to and at least just slightly beyondthe intermediate position of FIG. 7. At this point, endwise compressionof the lens by the contracted ciliary muscle produces a forward bucklingforce on the lens which effects final accommodation of the lens beyondthe intermediate position of FIG. 7 to the near vision position of FIG.8. Subsequent brain-induced relaxation of the ciliary muscle 28 inresonse to looking at a distant scene reduces the vitreous cavitypressure, stretches the capsular bag 20 to its maximum diameter, andrestores the anterior capsular rim 22 to its taut trampoline-likecondition to effect return of the lens to its distant viewing positionof FIG. 6. During accommodation, the lens optic 34 moves along the axisof the eye toward and away from the retina 16. The power of the optic isselected by the brain to sharply focus incoming light rays on the retinathroughout the range of this accommodation movement.

The lens haptics 36 flex at their hinges 38 with respect to the lensoptic 34 during accommodation. Any elastic strain energy forcesdeveloped in the hinges during this flexing produces additional anteriorand/or posterior forces on the lens. For example, assume that the lensis relatively flat, i.e., that the lens haptics 36 lie in a common planeas shown in FIG. 1, in the normal unstressed state of the lens. In thiscase, posterior deflection of the lens from its position of FIG. 1 toits distant vision position of FIG. 6 creates elastic strain energyforces in the hinges 38 which urge the lens forwardly back to itsunstressed position of FIGS. 1 and thus aid the above discussed initialaccommodation of the lens in response to contraction of the ciliarymuscle. Final accommodation flexing of the lens from its intermediateposition of FIG. 7 to its near vision position of FIG. 8 creates elasticstrain energy forces in the hinges 38 which urge the lens rearwarlytoward its unstressed position and thus aid initial return of the lensfrom its near vision position to its distant vision position in responseto relaxation of the ciliary muscle. The lens may be designed to assumesome other normal unstressed position, of course, in which case anyelastic strain energy forces created in the lens during flexing of thehaptics will aid, resist, or both aid and resist accomodation of thelens to its near vision position and return of the lens to its distantvision position depending upon the unstressed position of the lens.

During accommodation, the lens haptics 36 slide endwise in theirfibrosed tissue pockets 42. As shown best in FIGS. 2 and 3, the hapticsare tapered endwise in width and thickness to enable the haptics to movefreely in the pockets. The lens optic 34 moves toward and away from theanterior capsular rim 22. The diameter of the optic is made as large aspossible to maximize its optical imaging efficiency. The optic ispreferably but not neccessarily made smaller than the diameter of theanterior capsule opening 26 to permit accommodation movement of theoptic into and from the opening without interference by the capsular rim22 in order to maximize the accommodation range. The actual lensdimensions are determined by each patient's ocular dimensions. Thedimensions of a simple plate haptic intraocular lens according to theinvention will generally fall within the following ranges:

Optic diameter: 3.0 mm-7.0 mm Overall lens length:  9.0 mm-11.5 mmHaptic thickness: 0.25 mm-0.35 mm

Refer now to FIGS. 9-15 illustrating several possible alternative shapesof the accommodating intraocular lens. The modified lens 50 illustratedin FIG. 9 is identical to lens 32 of FIGS. 1-8 except that the haptichinges 38 of lens 32 are eliminated in the lens 50, and the haptics 52of the lens 50 are flexible throughout their length, as illustrated bythe broken lines in FIG. 9. The modified lens 54 in FIG. 10 has ananteriorly arched unstressed shape and includes a bi-convex optic 56,flexible hinges 58, and anteriorly vaulted haptics 60 with convexanterior surfaces 62. The convex anterior face 64 of the optic 56 andthe convex anterior haptic surfaces 62 are rounded to a common radius.The modified intraocular lens 66 in FIG. 11 is relatively flat andincludes an optic 68 having a planar Fresnel anterior face 70 and aconvex posterior face 72, haptics 73, and flexible haptic hinges 74. Themodified lens 76 in FIG. 12 has a posteriorly arched unstressed shapeand includes an optic 78 having a planar anterior face 80 and a convexposterior face 82, haptics 84 having convex posterior surfaces 86 andhaptic hinges 88. The posterior face 82 of the optic 78 and theposterior surfaces 86 of the haptics 84 are rounded to a common radius.The modified lens 90 illustrated in FIGS. 13 and 14 includes an optic 92and flexible haptics 94 and has an unstressed near vision configurationshown in FIG. 13. The haptics flex to permit posterior deflection of thelens to its distant vision configuration of FIG. 14. The optic 92 isposteriorly offset relative to the inner ends of the haptics to permitgreater anterior displacement of the optic during accommodation withoutcontacting the anterior capsular rim 22 of the capsular bag 20. Themodified intraocular lens 100 of FIG. 15 includes haptics 102 and anoptic 104 which is offset anteriorly relative to the inner ends of thehaptics. The haptics are joined to diametrically opposite sides of theoptic by flexible hinges 106.

The modified intraocular lenses of FIGS. 9-15 are implanted within thecapsular bag 20 of the eye 10 and utilize the posterior bias of thefibrosed capsular rim 22, the posterior capsule 24, changes in vitreouscavity pressure, and the patient's ciliary muscle action to effectaccommodation in the same manner as described in connection with theintraocular lens 32 of FIGS. 1-8. In the case of the lens 100 in FIG.15, the outer ends of its haptics 102 are implanted within the capsularbag 20 in essentially the same way as the haptics of lens 32 so thatfibrosis of the rim 22 occurs about the haptics in the same manner asdescribed in connection with FIGS. 1-8. The anteriorly offset optic 104of the lens 100, on the other hand, protrudes through the anterioropening 26 in the capsular bag 20 and is situated anteriorly of the rimand between the rim and the iris 18 of the eye. There is sufficientspace between the rim and the iris to accommodate the optic of aproperly sized lens without the optic contacting the iris.

FIGS. 16-20 illustrate modified accommodating intraocular lensesaccording to the invention having means for fixating or anchoring thelens haptics in the capsular bag 20 to prevent the lenses from enteringthe vitreous cavity 21 of the eye in the event that the posteriorcapsule 24 becomes torn or a posterior capsulotomy must be performed onthe posterior capsule because it becomes hazy. Except as noted below,the modified intraocular lenses of FIGS. 16-20 are identical to the lens32 of FIGS. 1-8 and are implanted in the capsular bag 20 of the eye 10in the same manner as described in connection with FIGS. 1-8. Theintraocular lens 110 of FIGS. 16 and 17 is identical to lens 32 exceptthat the outer ends of the lens haptics 112 have raised shoulders 114.Fibrosis of the capsular rim 22 around the haptics 112 and theirshoulders 114 anchors or fixates the lens 110 in the capsular bag 20.The intraocular lens 116 of FIG. 18 is identical to lens 32 except thatflexible stalk-like knobs 118 extend diagonally from the outer ends ofthe lens plate haptics 120. The distance between the outer ends of thediametrically opposed knobs 118 is slightly larger than the distancebetween the outer ends of the lens haptics and slightly larger than thediameter of the capsular bag 20. The knobs are set wider than the widthof the lens body. These two features help to center the intraocular lenswithin the capsular bag so that the lens optic is centered immediatelybehind the circular capsulotomy 26 in the bag. Fibrosis of the capsularrim 22 around the haptics 120 and their knobs 118 fixes the lens 116 inthe capsular bag 20. The intraocular lens 122 of figure. 19 is identicalto lens 32 except that the outer ends of the lens haptics 124 haveopenings 126. Fibrosis of the capsular rim 22 occurs around the haptics124 and through their openings 126 to fixate the lens 122 in thecapsular bag 20. The intraocular lens 128 of FIG. 20 is similar to thelens 122 in that the lens 128 has openings 130 in the outer ends of itshaptics 132 through which fibrosis of the capsular rim 22 occurs tofixate the lens in the capsular bag 20. Unlike the lens 122, however,the haptic openings 130 are bounded along the outer ends of the hapticsby spring loops 134. The overall length of the lens 128, measuredbetween the centers of the spring loops 134 is made slightly greaterthan the maximum diameter of the capsular bag. The spring loops 134press against and are deformed inwardly slightly by the outercircumference of the capsular bag to center the lens in the eye duringfibrosis.

The modified intraocular lens 140 of FIG. 21 is identical to the lens 32of FIGS. 1-8 except that the lens 140 has centration nipples 142projecting endwise from the outer ends of the lens haptics 144 tocompensate for slight differences, from one patient to another, in thediameter of the human capsular bag 20. Thus, the diameter of thecapsular bag varies from about 11 mm in high myopes to about 9.5 mm inhigh hyperopes. The centration nipples 142 prevent differences in thedegree of flexing of the haptics 144 in capsular bags of differentdiameters. For example, in a hyperopic eye with a small capsular bag,the lens haptics would flex more with marked posterior vaulting of thelens by the fibrosed capsular rim compared to the minimal vaulting ofthe haptics which would occur in high myopes with relatively largecapsular bags. The nipples indent themselves into the outercircumference of the capsular bag to compensate for such differing bagdiameters and thereby center the lens in the bag.

The modified intraocular lens 150 illustrated in FIGS. 22-24 comprises alens body 152 proper identical to that of FIGS. 1-8 and springs 154 inthe form of U-shaped hoops constructed of biologically inert springmaterial. The ends of these springs are fixed to the anterior sides ofthe lens haptics 156 adjacent the haptic hinges 158 in such a way thatthe arched ends of the springs extend a small distance beyond the outerends of the haptics. The springs are stressed to normally lie relativelyclose to the anterior sides of the haptics. The lens body 152 isimplanted within the capsular bag 20 of the eye 10 in the same way asdescribed in connection with the lens 32 of FIGS. 1-8, and with theouter arched ends of the lens springs 154 lodged within the sulcus 19 ofthe eye between the iris 18 and the cornea 12. When the lens is in theposition of FIG. 23 which it occupies immediately after surgery as wellas after some degree of accommodation, the springs 154 lie relativelyclose to the anterior sides of the lens haptics 156. During posteriordisplacement of the lens to its distant vision position of FIG. 24 bythe posterior bias of the fibrosed capsular rim 22, the springs aredeflected anteriorly away from the lens haptics, as shown, therebycreating in the springs elastic strain energy forces which aid thestretched posterior capsule 24 and vitreous cavity pressure indisplacing the lens anteriorly during accommodation in response tocontraction of the ciliary muscle 28.

FIGS. 25-32 illustrate modified intraocular lenses according to theinvention having a lens body and separate lens fixation elements forpositioning the lenses in the capsular bag 20. Fibrosis of the capsularrim 22 occurs around these fixation elements in a manner which securelyfixes the elements within the bag. In some figures, the lens body isseparable from the fixation elements to permit removal of the lens fromand replacement of the lens in its original position in the eye. Inother figures, the lens body and fixation elements are secured againstseparation to prevent entrance of the lens body into the vitreouschamber in the event a tear develops in the posterior capsule 24 of thebag or a posterior capsulotomy is performed in the capsule.

The modified lens 160 of FIG. 25 includes a lens body 162 which isidentical, except as noted below, to that of lens 32 in FIGS. 1-8 andseparate fixation elements 164 at the outer ends of the lens haptics166. The fixation elements and haptics are interengaged in such a waythat the elements and haptics are capable of relative movementlengthwise of the haptics when the haptics flex during accommodation ofthe lens. The fixation elements 164 in FIG. 25 are generally U-shapedloops of biologically inert material having legs 168 which slide withinlongitudinal sockets 170 entering the outer ends of the haptics 166. Thehaptics 166 are somewhat shorter in length than those of the lens 32,and the overall length of the lens, measured between the outer archedends of the fixation loops 164, when their legs 168 abut the bottoms oftheir sockets 170, is less than the maximum diameter of the capsular bag20 when the ciliary muscle 28 is relaxed and greater than the diameterof the bag when the ciliary muscle is fully contracted foraccommodation. The lens 160 is implanted within the capsular bag 20 ofthe eye 10 with the fixation loops 164 and the outer ends of the haptics166 disposed between the anterior rim 22 and posterior capsule 24 of thecapsular bag 20. The outer arched ends of the loops are situated at theouter circumference of the bag.

Fibrosis of the capsular rim 22 occurs around the outer ends of the lenshaptics 166 and the exposed outer ends of the fixation loops 164 andthrough the spaces between the haptics and the loops in such a way thatthe loops are firmly fixed in the capsular bag, and the haptics formpockets 42 in the fibrose tissue F. The posterior bias of the fibrosedcapsular rim 22 urges the lens posteriorly to its distant visionposition when the ciliary muscle 28 is relaxed, thereby stretching theposterior capsule 24 rearwardly in the same manner as explained inconnection with FIGS. 1-8. When the ciliary muscle contracts duringaccommodation, the vitreous cavity pressure increases and the capsularrim 22 relaxes,thereby permitting the stretched posterior capsule andthe vitreous cavity pressure to push the lens body 162 forwardly towardits near vision position, again in the same manner as explained inconnection with FIGS. 1-8. Contraction of the capsular bag in responseto contraction of the ciliary muscle during accommodation displacementexerts inward forces on the fixation loops 164. These inward forces urgethe loops inwardly in their haptic sockets 170 until the loops abut thebottoms of the sockets. The inward forces exerted on the loops thenproduce an anterior buckling moment on the lens body 162 which aidsaccommodation of the lens by the posterior capsule. During thisaccommodation, the lens haptics 166 flex posteriorly relative to thelens optic 172 and slide inwardly in their fibrose pockets 42 and alongthe legs 168 of the fixation loops 164, the movement being aided byhinges 38.

The fixation loops have holes 174 in their outer arched ends throughwhich a suture 176 may be passed and tied to retain the loops and lensbody in assembled relation during implantation of the lens in thecapsular bag. This suture is removed at the conclusion of the surgery.Holes 174 may also be utilized to position the lens in the capsular bagduring surgery. The lens haptics 166 are separable from and reengageablewith the fixation loops 164. This permits the lens body 162 to beremoved from the eye any time after surgery for correction orreplacement of the lens optic 172 and then replaced in its originalposition in the eye.

The modified intraocular lens 180 of FIG. 26 is similar to that of FIG.25 except for the following differences. First, the haptics 182 of lens180 are substantially the same length as the haptics of lens 32 and havecutouts 184 in their outer ends. The legs 188 of the fixation loops 186slide in sockets 190 which enter the bottom edges of the cutouts 184.When the lens is implanted within the capsular bag 20, the tongue-likehaptic portions at opposite sides of the haptic cutouts 184 and theouter arched ends of the fixation loops 186 are situated within theouter circumference of the bag. As with the lens of FIG. 25, fibrosis ofthe capsular rim 22 occurs around the haptics 182 and fixation loops 186and through the spaces between the haptics and loops so as to firmly fixthe loops in the capsular bag and form pockets within which the hapticsslide when they flex during accommodation of the lens. Secondly, thelegs 188 of the fixation loops 186 and their sockets 190 in the lenshaptics 182 are tapered to facilitate free relative movement of theloops and haptics when the haptics flex during accommodation. Thirdly,the fixation loops have fixation nipples 192 at their outer arched endswhich indent into the outer circumference of the capsular bag 20 toretain the lens against movement relative to the bag during fibrosis.

FIG. 27 illustrates a modified intraocular lens 196 like the lens 180illustrated in FIG. 26 except that the legs 198 of the fixation loops200 and the haptic sockets 202 which receive these legs have coactingshoulders 204, 206. These shoulders permit limited relative movement ofthe lens body 208 and loops when the haptics 210 flex during lensaccommodation, but secure the lens body and loops against completeseparation so as to prevent the lens body from entering the vitreouschamber 21 if a tear occurs or a capsulotomy is performed in theposterior capsule 24. Another difference between the lens 196 and thelens 180 resides in the fact that the hinges 212 connecting the innerends of the haptics 210 to the lens optic 214 extend across only anintermediate portion of the haptic width. The remaining lateral portionsof the inner haptic ends beyond the ends of the hinges are separatedfrom the optic by arcuate slots 216 centered on the axis of the optic.These separations of the haptics from the optic permit the optic to movefreely into and from the anterior opening 26 in the capsular bag 20without interference with the capsular rim 22 during lens accommodation.The generally triangular haptic portions adjacent the slots 216 preventthe rim 22 of the capsular bag 20 from fibrosing between the lens optic214 and the inner ends of the lens haptics 210 and thereby restrictingendwise movement of the haptics in their fibrosed pockets 42.

The modified lens 220 of FIG. 28 includes a lens body 222 and separatefixation elements 224 at the outer ends of the lens haptics 226. Theinner ends of the haptics are convexly curved and disposed in generallytangential relation to diametrically opposite sides of the lens optic228 so as to provide relatively large clearance spaces 230 between theoptic and the inner haptic ends. The haptics and optic are joined alongtheir tangential portions by flexible hinges 232. The fixation elements224 are generally cruciform shaped pins having inner journals 234 whichslide within bearing bores 236 entering the bottom edges of cutouts 238in the outer ends of the haptics 226. These fixation pins have holes 240between their ends, outer cross arms 242, and nipples 244 at their outerends. The length of the lens 220 measured between the outer ends of itshaptics 226 and fixation pins 224 approximates the maximum innerdiameter of the capsular bag 20 when the ciliary muscle is relaxed. Thefixation pin journals 234 and their bores 236 have coacting shoulders246, 248 which permit limited relative movement of the lens body andfixation pins when the haptics flex during accommodation but secure thebody and fixation pins against complete separation, for the same reasonsas explained above in connection with FIG. 27. If desired, the shoulders246, 248 may be eliminated to permit separation of the fixation pins andlens body for the same reasons as explained in connection with FIG. 26.If the shoulders are eliminated, a removable suture may be threadedthrough the fixation pin holes 240 and tied to hold the fixation pinsand lens body in assembled relation during implantation of the lens, asexplained in connection with FIG. 25. The holes may also be used toposition the lens in the capsular bag during implantation of the lens.

When the lens 220 is implanted within the capsular bag 20 of the eye 10,the outer ends of the lens haptics 226 and the fixation pins 224 aredisposed between the capsular rim 22 and posterior capsule 24 of the bagin much the same way as described in connection with FIGS. 25-27. Thenipples 244 indent the outer circumference of the bag to fix the lensagainst rotation circumferentially around the bag and center the lens inthe eye during fibrosis of the rim 22. Fibrosis of the capsular rimoccurs about the outer ends of the haptics and the fixation pins tofirmly fix the pins in the bag and form pockets in the fibrosed tissuereceiving the haptics. The lens body 222 is urged posteriorly to itsdistant vision position by the posterior bias of the capsular rim 22when the ciliary muscle 28 relaxes and anteriorly toward its near visionposition during accommodation by the stretched posterior capsule 24 andincrease in vitreous cavity pressure when the ciliary muscle contracts,all in essentially the same way as explained earlier in connection withFIGS. 25-27. During anterior accommodation of the lens, contraction ofthe capsular bag 20 in response to contraction of the ciliary muscleexerts inward forces on the outer ends of the haptics 226 which producean anterior buckling moment on the lens body 222 that aids lensaccommodation by the posterior capsule. The cross arms 242 of thefixation pins 224 are enveloped by the fibrosed tissue F during fibrosisof the rim 22 to provide pivots about which the pins can rotate duringbuckling of the lens body in the course of lens accommodation. Thespaces 230 between the inner ends of the haptics 226 and the optic 228accommodate movement of the optic into and from the opening 26 in thecapsular bag without interference with the surrounding capsular rim 22.

The modified intraocular lenses 260, 262 in FIGS. 29 and 30 areidentical to the lenses 180, 196, respectively, in FIGS. 26 and 27except that the fixation loops of the latter lenses are replaced, inFIGS. 29 and 30, by fixation pins 264, 266 like those in FIG. 28.

The modified intraocular lenses 270, 272 in FIGS. 31 and 32 areidentical to the lens 32 of FIGS. 1-8 except that lens 270 has lateralspring arms 274 which extend from the haptic hinges 276 and lens 272 haslateral spring arms 278 which extend from the edges of the lens haptics280. The arms 274, 278 extend laterally from and longitudinally towardthe outer ends of the lens haptics in such a way that in their normalunstressed positions, the arms are disposed at acute angles relative tothe longitudinal axes of the lenses. The arms are sized in length sothat when the lenses are implanted within the capsular bag 20 of theeye, the outer ends of the arms press against the outer circumference ofthe bag and are thereby curled or compressed to the positionsillustrated in broken lines. The curl or compression in the armsdecreases when the capsular bag expands in response to relaxation of theciliary muscle during distant vision accommodation of the lens andincreases when bag contracts in response to contraction of the ciliarymuscle during near vision accommodation of the lens. Engagement of thearms with the capsular bag circumference acts to center the lenses inthe bag in a position wherein the lens optics 282, 284 are coaxiallyaligned with the anterior bag opening 26. Fibrosis of the capsular rim22 occurs about the spring arms to fix the lenses within the capsularbag and about the lens haptics to form pockets in which the hapticsslide when they flex during accommodation of the lenses. Referring toFIG. 32 and to FIGS. 4 to 8, projections such as those indicated at 286in FIG. 32, may preferably be provided in various embodiments of theinvention to space the capsulorhexis from the optic when thecapsulorhexis constricts from its configuration shown in FIGS. 5 to 8.This spacing prevents the anterior capsular rim 22, with a relativelysmall capsular opening 26, from encroaching onto the optic duringfibrosis of capsular rim 22. As shown in FIG. 32, such projections 286extend outwardly anteriorly from the plate haptic surface, and aredisposed about and spaced from the optic. The projections extendoutwardly no farther than the outer extent of the optic, typically to aheight of about 1-1.5 mm. The projections may be in the form ofcontinuous arcs (not shown) and may be inclined outwardly relative tothe optic.

The modified accommodating intraocular lens 290 of FIG. 33 comprises acircular optic 292 and two pairs 294, 296 of curved, flexible haptics298, 300 extending from opposite edges of the optic. These haptics havethe form of relatively slender arms. At the outer ends of the hapticsare enlarged knobs 302. The two haptics 298 of each haptic pair 294, 296extend out from the optic 292 in mutually divergent relation and curveaway from one another toward their outer ends, as shown. The fourhaptics are disposed in symmetrical relation relative to a plane ofsymmetry containing the axis of the optic and passing midway between thetwo haptics of each haptic pair. The two haptics 298 are locateddiametrically opposite one another, and the two haptics 300 are locateddiametrically opposite one another. The diametrical distance measuredbetween the outer ends of the diametrically opposed haptics 298, 300 ismade slightly greater than the maximum diameter of capsular bag 20. Thelens 290 is implanted within the bag in much the same manner as theearlier embodiments of the invention and with the outer ends of the lenshaptics 298, 300 disposed between the anterior capsular rim 22 andposterior capsule 24 of the bag. The outer ends of the haptics pressresiliently against the outer circumference of the bag and flex or bendin such a way as to both accommodate bags of different diameter andcenter the optic 292 behind the anterior capsulotomy in the bag. Theanterior capsular rim 22 of the bag fibroses about the haptics to fixatethe lens in the bag. After fibrosis is complete, brain initiatedrelaxation and constriction of the ciliary muscle 28 of the eye iseffective to cause accommodation of the lens between near and distantvision positions in essentially the same manner as described earlier.During this accommodation, the lens buckles and the haptics flexanteriorly and posteriorly relative to the optic 292 in much the sameway as described earlier. Fibrosis of the capsular rim about the hapticknobs 302 fixates the lens in the capsular bag and against dislocationin the event a tear or capsulotomy is formed in the posterior capsule 24of the bag.

The modified accommodating intraocular lens 310 of FIG. 34 is similar tothe lens 290 of FIG. 33 and differs from the lens 290 only in thefollowing respects. The four haptics 312, 314 of the lens 310, ratherthan being slender curved arms like those of lens 290, are symmetricallytapered from relatively wide inner ends which are joined to the lensoptic 316 to relatively narrow outer ends. At the outer ends of thehaptics 312, 314 are enlarged knobs 318. At inner ends of the hapticsare grooves 320 which form flexible hinges 322 about which the hapticsare flexible anteriorly and posteriorly of the optic. The diametricaldistance between the outer ends of the diametrically opposed haptics312, 314 approximates or slightly exceeds the maximum diameter of thecapsular bag 20. The lens 310 is implanted within the bag, and fibrosisof the anterior capsular rim 22 of the bag occurs about the lens hapticsin the same way as described in connection with lens 290. After fibrosisis complete, brain initiated relaxation and constriction of the ciliarymuscle 28 of the eye cause accommodation of the lens in the same manneras described in connection with lens 290. Fibrosis of the capsular rimabout the haptic knobs 318 fixates the lens in the capsular bag andagainst dislocation in the event a tear or capsulotomy is formed in theposterior capsule 24 of the bag.

The accommodating plate haptic lenses described to to this point arereferred to herein as simple plate haptic lenses. These lenses areintended for use when the anterior capsulotomy procedure performed onthe eye provides an anterior annular capsular remnant or rim thatremains intact and circumferentially continuous throughout fibrosis andhas a sufficient radial width to retain the lens in the proper positionwithin the capsular bag during and/or after fibrosis. According toanother of its aspects, this invention provides modified accommodatingintraocular lenses, illustrated in FIGS. 38-40 and 43-46 and referred toas plate haptic spring lenses, for use when the anterior capsularremnant or rim of the capsular bag is ruptured, that is cut or torn, orhas too small a radial width to firmly retain the lens in properposition during and/or after fibrosis.

As noted earlier, a ruptured capsular remnant or rim may occur indifferent ways. For example, continous tear circular capsulotomy, orcapsulorhexis, (FIG. 35) involves tearing the anterior capsule of thenatural lens along a circular tear line to form in the anterior capsulea circular opening or capsulotomy 400 circumferentially surrounded by anannular remnant or rim 402 of the anterior capsule. Improper performanceof this capsulorhexis can easily create slits or tears 404 in thecapsular rim. A beer can or can opener capsulotomy (FIG. 36) involvespiercing the anterior capsule of the natural lens at a multiplicity ofclose positions 404 along a circular line and removing the circularportion of the anterior capsular rim within the pierced line to form ananterior capsule opening 406 circumferentially surrounded by an annularrim 408. While this rim may be initially intact and circumferentiallycontinuous, it has an inner scalloped edge 410 having stress-inducingregions that render the rim very prone to tearing radially, as shown at411, during surgery or subsequent fibrosis. An envelope capsulotomy(FIG. 37) involves slitting the anterior capsule of the natural lensalong a horizontal line 412, then along vertical lines 414 extendingupwardly from and intersecting the horizontal slit, and then tearing theanterior capsule along a tear line 416 which arches upwardly from theupper end of the vertical slit and then extends vertically downward tojoin the second vertical cut. This capsulorhexis produces an anteriorcapsule opening 418 bounded by a capsular remnant 420 which is slit at412 and hence is inherently ruptured.

A ruptured anterior capsular remnant or rim may preclude utilization ofa simple plate haptic lens of the invention for the following reasons. Aruptured rim may not firmly retain the lens haptics in the sulcus of thecapsular bag during fibrosis. This renders the lens prone todecentration and/or dislocation, such as dislocation into the vitreouscavity if the posterior capsule tears or becomes cloudy over a period oftime and is cut with a laser to provide a capsulotomy in the posteriorcapsule. A ruptured capsular rim may be incapable of assuming the tauttrampoline-like condition of an intact capsular rim. As a consequence, aruptured capsular rim may be incapable of effecting full posteriordeflection of a plate haptic lens to a distant viewing position againstthe posterior capsule during and after fibrosis. A ruptured capsular rimmay also permit anterior deflection of the lens during fibrosis. Ineither case, since the power of an intraocular lens is selected for eachindividual patient and may be dependent upon their spectacle power, andsince good vision without glasses requires the lens optic to be situatedat precisely the correct distance from the retina throughout the rangeof accommodation, a simple plate haptic lens of the invention may not beacceptable for use with a ruptured anterior capsular remnant or rim.

FIGS. 38-40 illustrate an accommodating plate haptic spring intraocularlens 420 of the invention for use with a ruptured anterior capsularremnant or rim, such as any one of those illustrated in FIGS. 35-37.This plate haptic spring lens has a lens body 422 proper similar to thatof the plate haptic lens 32 in FIGS. 1-8 and springs 424 at the ends ofthe body. The lens body 422 includes a central optic 426 and flexibleplate haptics 428 extending outward from diametrically opposite sides ofthe optic. These haptics are joined to the optic by hinges 429 formed bygrooves in the anterior side of the lens. The springs 424 are resilientloops which are staked at one end to the ends of the haptics 428 atopposite sides of the longitudinal centerline of the body. These springloops bow outwardly lengthwise of the lens body from their staked endsto their centers and then turn back toward the lens body from theircenters to their free ends. The ends of the haptics 428 have recesses430 over which the spring loops extend in such a way that the loops andthe edges of the recesses form openings 432 therebetween. The ends ofthe spring loops have holes 433 to receive instruments for positioningthe lens in the eye.

The plate haptic spring lens 420 is implanted within the capsular bag 20of the eye in the same manner as described earlier in connection withthe simple plate haptic lenses of the invention. That is to say, thelens 420 is implanted within the eye while its ciliary muscle 28 isparalyzed in its relaxed state, and the capsular bag is therebystretched to its maximum diameter (9-11 mm). The overall length of thelens body 422 measured between the ends of the lens haptics 428 ateither side of the haptic recesses 430 substantially equals the innerdiameter of the stretched capsular bag. The overall length of the lensmeasured between the outer edges of the spring loops 424 at theircenters when the loops are in their normal unstressed state is slightlygreater than this inner diameter of the stretched capsular bag. Forexample, if the inner diameter of the stretched capsular bag is in therange 10-10.6 mm, the lens body 422 will have an overall length of10-10.6 mm measured between the outer ends of the lens haptics, and theoverall length of the lens measured between the centers of theunstressed spring loops will be in the range of 11-12.5 mm.

FIGS. 39 and 40 illustrate the plate haptic spring lens 420 implanted ina capsular bag 20 which is stretched by relaxation of the ciliary muscle28 and has a torn anterior capsular rim 22 such as might result from animproperly performed continuous tear circular capsulorhexis. Because therim is torn, the lens body 422 will not fit as snugly in the stretchedbag as it would if the capsular rim were an intact rim free of tears.The haptic spring loops 424, however, press outward against the wall ofthe capsular bag sulcus about the rim of the bag to fixate the lens inthe bag during fibrosis following surgery. Fibrosis of the torn capsularrim 22 occurs about the outer ends of the plate haptics 428, about thespring loops 424, and through the openings 432 between the loops and theends of the haptics in such a way as to effect fusion of the torn rim,or more precisely the remnants of the torn rim, to the posterior capsule24 of the capsular bag. The outer ends of the haptics and the springloops are thereby shrink-wrapped by fibrosis in somewhat the same manneras explained earlier in connection with the simple plate haptic lensesof the invention. Even though the torn capsular rim 22 may be incapableof stretching to the taut trampoline conditon discussed earlier when theciliary muscle is relaxed, this shrink-wrapping of the lens duringfibrosis of the torn rim will firmly fixate the lens in the capsular bagand should cause some posterior deflection of the lens against theelastic posterior capsule 24. Accordingly, brain-induced constrictionand relaxation of the ciliary muscle 28 after fibrosis of the torncapsular rim is complete should effect accommodation of the plate hapticspring lens in much the same way, but possibly not with the same amountof accommodation, as the simple plate haptic lens with an intactnon-ruptured capsular rim.

While the plate haptic spring lens 420 is designed for use with aruptured anterior capsular remnant or rim, it can also be utilized withan intact rim. A plate haptic spring lens also compensates for improperlens placement in the eye with one end of the lens situated in thecapsular bag and the other end of the lens situated in the ciliarysulcus of the eye since the spring loops will expand outwardly to engageboth the inner edge of the bag and the wall of the ciliary sulcus. Inthis regard, an advantage of the plate haptic spring lenses of theinvention over the simple plate haptic lenses resides in the fact thatthe spring lenses eliminate the need to have on hand in the operatingroom both a simple plate haptic lens for use with an intact capsular rimand a plate haptic spring lens as a backup for the plate haptic lens inthe event the rim is ruptured during surgery.

Another advantage of the haptic spring lens 420 resides in the fact thatit permits the lens to have a larger optic than a simple plate hapticlens whose optic diameters will normally be within the range of 4-7 mm.Thus, since the haptic spring lens relies on the spring loops 424 ratherthan on the capsular remnant or rim 22 to retain the lens in positionduring fibrosis, the lens may be used with a capsular remnant or rim ofsmaller radial width and hence larger diameter anterior capsule openingthan those required for use of the simple plate haptic accommodatinglenses. The larger diameter anterior capsule opening, of course, permitsa larger optic diameter in the range of 7-9 mm which offers certainophthalmological benefits.

The large diameter anterior capsule opening necessary to accommodate alarge optic spring accommodating lens may be formed during the originalsurgery by a planned large continuous tear circular capsulorhexis, abeer can capsulotomy of the desired large diameter, a planned envelopecapsulotomy or by cutting of radial slits into the anterior capsular rimduring surgery after implanting the spring accommodating lens in thecapsular bag. According to another of its aspects, the inventionprovides a method whereby the desired large anterior capsule opening maybe formed after the original surgery following completion of fibrosis.This method involves slitting an annular capsular rim radially with alaser after fibrosis is complete into a number of flap-like remnants 434(FIG. 41) which are easily displaced by the lens during accommodation topermit the lens optic to pass through the anterior capsule opening.Alternatively, the anterior capsule opening may be enlarged by cuttingthe capsular rim with a laser circumferentially along a circular line436 (FIG. 42) concentric with and radially outwardly of the originaledge of the opening to enlarge the latter.

The modified plate haptic spring lens 500 of FIG. 43 is identical to thelens 420 just described except that the haptics 502 of the modifiedlens, rather than being hinged to the lens optic 504, are resilientlyflexible throughout their length like those of the plate haptic lens inFIG. 9. FIG. 44 illustrates a further modified plate haptic spring lens600 according to the invention which is identical to the lens 420 exceptthat the spring loops 602 of the modified lens are formed integrallywith the lens haptics 604. The modified lens 700 and 800 of FIGS. 45 and46 are identical to the lens 600 except that the modified lenses have apair of spring loops at each end. The spring loops 702 of lens 700 havecommon base portions 704 integrally joined to the ends of the lenshaptics 706 along the longitudinal centerline of the lens and free endswhich curve outwardly from the base portions both endwise and laterallyof the lens. The spring loops 802 of lens 800 have base portions 804integrally joined to the ends of the lens haptics 806 along thelongitudinal edges of the haptics and opposite free ends which curveinwardly toward one another laterally of the lens.

FIGS. 47-50 illustrate the presently preferred accommodating intraocularlens of the invention. The illustrated lens 900 is a plate haptic springlens having a body 902 including a round bi-convex optic 904 and platehaptics 906 joined to diametrically opposite sides of the optic by hingejunctions 908.

Haptics 906 have relatively wide outer end portions 910, inwardlytapered central portions 912, and relatively narrow tapered inner endportions 914. The inner end portions 914 are joined to diametricallyopposite edge portions of the round optic 904. The width of the outerend portions 910 of the haptics measured transverse to the length of thelens approximates the diameter of the optic. The width of the innerhaptic end portions 914 measured transverse to the length of the lens issubstantially less than the diameter of the optic. The outer endportions 910 and tapered central portions 912 of the haptics occupy themajor length of the haptics measured in the lengthwise direction of thelens. The tapered inner end portions 914 of the haptics taper inwardlyto a progressively narrower width toward the outer ends of the haptics.These inner end portions effectively form bridges between the optic andthe wide outer major portions 910 of the haptics. The inner haptic endportions contain V-grooves 916 which extend across the anterior sides ofthese end portions transverse to the length of the lens close to andpreferably in virtually tangential relation to the edge of optic 904.

The outer end portions 910 of the haptics 906 contain relatively largeopenings 918 in the form of cutouts which open through the outer ends ofthe haptics. Joined at one end to the outer ends of the haptics, at oneside of the open ends of the haptic cutouts 918, are spring arms 920.These arms extend laterally across the outer haptic ends and areresiliently flexible endwise of the lens.

As shown in FIG. 48, the optic 904 is offset anteriorly relative to theplate haptics 906. That is to say, a plane median plane) containing thecircumferential edge of the lens is offset anteriorly along the lensaxis relative to a plane (median plane) passing through the hapticsparallel to and midway between their anterior and posterior sides. Thisanterior offset of the optic provides groove-like recesses 924 at theposterior side of the lens along the junctures of the optic and theinner ends 914 of the haptics. The relatively thin web-like portions ofthe lens body between the anterior grooves 916 and posterior recesses924 are resiliently flexible and form the hinge junctions 908 aboutwhich the lens haptics are flexible anteriorly and posteriorly relativeto the lens optic.

Referring to FIG. 49, the lens 900 is implanted in the capsular bag 20of a patient's eye, and following completion of fibrosis, undergoesaccommodation in response to contraction and relaxation of the ciliarymuscle 28 in much the same manner as described in connection with theearlier described lens embodiments of the invention. The spring arms 920of the lens press outwardly against the outer perimeter of the bag toposition the lens in the baq even through the anterior remnant 22 of thebag may be slit, torn, or otherwise not intact, in the same manner asdescribed in connection with FIGS. 38-40. During fibrosis of theanterior capsular rim 22 of the bag 20 to the elastic posterior capsule24 following surgery, fibrosis occurs around the lens haptics 906 andthrough the haptic openings 918 to fixate the lens in the capsular bag.The ciliary muscle 28 is maintained in its relaxed state until fibrosisis complete by introducing a cycloplegic into the eye, as explainedearlier.

The anterior offset of the optic 904 in the preferred lens 900 providestwo advantages. One of these advantages resides in the fact that thearrangement of the hinge junctions 908 resulting from the anterioroffset of the optic 904 aids anterior buckling of the lens and therebyaccommodation movement of the optic relative to the outer ends of thehaptics 906 in response to endwise compression of the lens bycontraction of the ciliary muscle 28. The other advantage resides in thefact that the hinge junctions 908 which join the haptics 906 to thediametrically opposite edge portions of the optic 904 are relativelynarrow compared to the diameter of the optic and are preferably narrowerthan the radius of the bag, as shown. The hinge junctions thus occupyonly relatively small circumferential edge portions of the optic. Theremaining circumferential edge portions of the optic between thejunctions are free edge portions which are totally unobstructed by thehaptics and taken together constitute a major portion of the opticcircumference. The diameter of the optic is made to approximate or beslightly smaller than the anterior capsule opening 26 in the capsularbag in which the lens is implanted. These features of the lens enablethe lens to undergo increased anterior accommodation movement from itsposterior distant vision position of FIG. 49 to its forwardaccommodation limit of FIG. 50, in which the optic projects through theanterior capsule opening 26, in response to contraction of the ciliarymuscle 28. The inward taper of the inner bridge portions or ends 914 ofthe haptics permit these haptic portions to slide in and out of thecapsular bag haptic pockets during accommodation of the lens.

The actual dimensions of the preferred lens may vary depending upon thepatient's ocular dimensions. Following are typical lens dimensions:

Overall lens length: 10.5 mm

Overall lens length including springs: 11.5 mm

Optic diameter: 4.50 mm

Haptic outer end width: 4.50 mm

Haptic edge taper angle: 30 degrees

Length of inner haptic end portion: 0.75 mm

Haptic thickness: 0.25-0.4 mm

Hinge junction width: 1.50 mm

Lens material: silicone

In the lens 900 of FIGS. 48-50, the optic 904 is offset anteriorlyrelative to the haptics 906 within the thickness of the haptics in sucha way that both the circumferential edge of the optic and the hingejunctions 908 are situated within the thickness of the haptics andbetween their anterior and posterior surfaces. FIG. 51 is a longitudinalcross-section similar to FIG. 48 through a modified intraocular lens 900a of the invention which is identical to lens 900 except that the optic904 a of the lens 900 a is offset anteriorly relative to the haptics 906a outside the thickness of the haptics. That is to say, in the lens 900a, both the circumferential edge of the optic 904 a and the hingejunctions 908 a between the optic and haptics are located forwardly ofthe anterior surfaces of the haptics 906 a. This modified lensconfiguration provides the same advantages as that of FIGS. 48-50.

The modified accommodating intraocular lens 900 b of FIG. 52 isessentially identical to the lens 900 except for the followingdifferences. Integrally joined at their ends to and extending across theouter ends of the lens haptics 906 b are relatively slender bridges orarches 922 b which bound and close the adjacent sides or ends of thehaptic openings 918 b. These arches are typically 0.20 mm in width andcurved to a radius of 5.25 mm about the optical axis of the lens optic904 b. The arches may be either resiliently flexible or relativelyflexible or relatively rigid. The spring arms 922 b of the lens 900 bextend laterally across the outer ends of the haptics opposite the openends or sides of the haptic openings 918 b and are flexible endwise ofthe lens.

The modified accommodating lens 900 c of FIG. 53 is similar in manyrespects to the lens 900 b of FIG. 52 and differs from the latter lensas follows. The spring arms 920 b of lens 900 b are omitted in the lens900 c. The inner end or bridge portions 914 c of the lens haptics 906 care quite short in the endwise direction of the lens. In fact, thelength of the inner haptic end portions 914 c approximates or is justslightly longer than the width of the open sides of the haptic grooves916 c which form the haptic hinge junctions 908 c with the lens optic904 c about which the haptics are flexible anteriorly and posteriorlyrelative to the optic. As a consequence these hinge junctions occupy orconstitute almost the entire length of the inner haptic end portions 914c. The haptic end arches 922 c may be either resiliently flexible orrelatively rigid.

The lenses 900 a, 900 b, 900 c of FIGS. 51-53 are implanted in thecapsular bag of a patient's eye and provide vision accommodation inresponse to contraction and relaxation of the ciliary muscle inessentially the same manner as the lens 900 of FIGS. 47-50. In the caseof lenses 900 b, 900 c, however, fibrosis occurs through the closedopenings 918 b, 918 c in the lens haptics and about the haptic endarches 922 b, 922 c to fixate the lenses in the patient's eye. The lens900 c may be sized in length between the outer sides of its arches 922 cto fit closely in the capsular bag when the ciliary muscle is relaxed,and these arches may be made resiliently flexible to enable the archesto serve as springs which press against the perimeter of the bag toposition the lens in the bag in the same manner as the haptic springs ofthe earlier described plate haptic spring lenses even though theanterior remnant of the bag may be split, torn, or otherwise not anintact remnant.

Less inert materials utilized for intraocular lens components arepreferably selected to provide optimum fixation of lens portions in theperipheral portions of capsular bags, and to provide optimum centrationof the lens. Less fibrosis is formed about components formed of inertmaterials than about less inert materials. The less inert materialsresult in greater fibrosis being produced about the components. Suchmaterials include PMMA, Acrylic, Prolene (a Nylon) and Polyimide.

Fibrosis forms more tightly about those materials which are less inert,for the reason that the body treats such materials as foreign objects.Lens features such as protuberances, arms and loops, are preferablyformed of less inert material, and features intended for relativesliding movement in a capsular bag pocket formed by fibrosis, are formedof more inert materials, such as Silicone, Polyhema (Hydroxethylmethacrylate) or HEMA.

Referring now to FIGS. 54-56, as well as to FIGS. 62 and 63, there isillustrated an anteriorly biased accommodating intraocular lens 1000according to the invention in its posterior distant vision positionwithin the capsular bag 20 of a patient's eye. Lens 1000 is like thelens earlier described except in the following respects. The anteriorsurfaces 1002 of the thickened extended portions or plate haptics 1004of lens 1000 are flush with the anterior surface of the lens optic 1006.The posterior haptic surfaces 1008 incline rearwardly away from theanterior haptic surfaces 1002 from the outer haptic tips toward theirinner junctions with the optic 1006 and then forwardly toward theanterior haptic surfaces to define, with the peripheral edge of theoptic, posterior V-shaped notches which form thinned flexible hinges1010 at the inner haptic ends. The optic 1006 has a convexly roundedposterior surface 1012.

Lens 1000 is implanted in the capsular bag 20 in the same manner as theearlier described lenses and is subjected to the same ciliary musclecontraction and relaxation as the earlier described lenses during normalvision accommodation following completion of fibrosis. Lens 1000 is sosized and shaped that the posterior surfaces 1008 of its haptics 1004and the posterior surface 1012 of its optic 1006 contact the posteriorcapsule 24 of the bag 20. When the lens 1000 occupies its posteriordistant vision configuration of FIGS. 54-56 which it assumes in itsposterior distant vision position shown in the latter figures, itshinges 1010 are located a small distance forwardly of the haptic tipplane P of the lens, i.e., a plane passing through the outer tips of thehaptics 1004 and the annular haptic-tip-receiving sulcus of the capsularbag 20 normal to the axis of the lens and the eye. Accordingly, duringciliary muscle contraction in the course of normal accommodation, end toend or radial compression of the lens 1000 and vitreous pressure bothexert anterior accommodation forces on the lens optic 1006 throughoutits full accommodation range. This combined faction of the two forcesincreases the accommodation amplitude and hence diopters ofaccommodation of the lens.

FIGS. 62 and 63 illustrate two modified anterior biased accommodatingintraocular lenses 1000 a and 1000 b according to the inventionimplanted within a capsular bag 20 of a patient's eye. These modifiedanterior biased lenses are identical to and undergo accommodation inmuch the same manner as the anterior biased lens of FIGS. 54-56 with thefollowing exceptions, In lens 1000 a, only the posterior surfaces 1004 aof the extended portions or plate haptics 1002 a of the lens contact theposterior capsule 24 of the capsular bag. Accordingly, vitreous pressureacts only on these haptics during accommodation, and the lens optic isimmune to laser damage during laser capsulotomy of the posteriorcapsule. The posterior surface 1012 a of the lens optic 1006 a is spacedfrom the posterior capsule. In lens 1000 b, only the posterior surface1012 b of the lens optic 1006 b contacts the posterior capsule 24 of thecapsular bag. The posterior surfaces 1004 b of the plate haptics 1002 bof the lens are spaced from the posterior capsule. Accordingly, duringaccommodation, vitreous pressure acts only on the posterior surface ofthe optic.

Most of the accommodating intraocular lenses of the embodimentsheretofore described have hinged extended portions in the form ofhaptics with resiliently flexible haptic inges. FIGS. 60-61 illustratemodified lenses having extended portions in the form of pivotally hingedhaptics. Lens 1100 a of FIG. 60 includes a central optic 1102 a andplate haptics 1104 a (only one shown) extending oppositely from theoptic and joined by pivotal hinges 1106 a to the edge of the optic. Eachhaptic hinge comprises mating hinge portions 1108 a, 1110 a on therespective haptic and the optic, which pivotally interengage and connectthe haptics to the optic for anterior and posterior movement of thehaptics relative to the optic.

The accommodating intraocular lenses 1100 a and 1100 c of FIGS. 60 and61 are made from material not sufficiently firm or hard for the formingof hinge portions, and their hinge portions are separately fabricated ofmaterials suitably hard or firm for reinforcing hinge inserts or inlays,which are molded within the optics and the haptic plates of the lenses.The parts of lenses 1100 a and 1100 b are designated by the samereference numerals as the corresponding parts, with subscripts a and bfor the respective lenses.

The optic and each haptic plate may be molded or otherwise fabricatedfrom any suitable intraocular lens material including materials earliermentioned. These materials have suitable optical and other qualities foran intraocular lens. Some of the materials are sufficiently hard or firmto enable haptic hinge components to be molded or otherwise formedintegrally with the haptic plates, and each haptic hinge groove to bemolded or otherwise formed in the material of the lens optic, as shown.Each hinge portion of such embodiment would have a hinge groove orchannel along the edge of the optic which opens laterally outward towardthe optic, with each hinge groove being cylindrically curved, undercutand sized in transverse cross-section to pivotally receive the bead ofthe adjacent haptic tongue, whereby the bead is captivated in the grooveand the respective haptic is pivotally movable within certain anglesanteriorly and posteriorly relative to the optic.

The lens 1100 a of FIG. 60 comprises an elongated hinge plate 1120 awhich is encapsulated and extends edgewise through, forming areinforcing insert or inlay within, a respective haptic plate 1114 a. Atthe inner end of this hinge plate is a cross-bar 1122 a which extendsedgewise beyond the inner end of haptic plate 1114 a to form the tongue1112 a on the hinge portion 1108 a. At the outer end of each hinge plate1120 a are flexible fingers 1124 a. Each haptic hinge portion 1110 acomprises a bar which is encapsulated within and forms a reinforcinginsert or inlay in the edge of the lens optic 1102 a. Along the outeredge of the bar is the hinge groove or channel 1118 a which pivotallyreceives the cylindrical bead 1116 a along the adjacent hinge tongue1112 a.

The modified lens 1100 b of FIG. 61 is like lens 1100 a except that theinner end of each haptic plate 1114 b extends edgewise beyond the innercross-bar 1122 b of the reinforcing hinge plate which forms therespective haptic hinge portion 1108 b of lens 1100 b. This extendinginner end of each haptic plate 1114 b has a cylindrically roundedsurface and a central slot 1126 b. Each haptic hinge portion comprises ahinge bar 1128 b encapsulated in the edge of the lens optic 1102 b andhaving a central rounded hinge projection 1130 b. This hinge projectionfits rotatably within slot 1126 b of hinge portion 1108 b, thus to formthe respective haptic hinge 1106 b with hinge pin 1132 b, which extendsthrough aligned bores in the haptic hinge portion in the optic hingeprojection.

FIGS. 57-59 illustrate a presently preferred accommodating intraocularlens 1050 according to the invention implanted within a capsular bag 20of a patient's eye. This preferred lens is an anteriorly biased lenswith flexibly hinged extended haptic portions, which achieves increasedaccommodation amplitude and increased diopters of accommodation by thecombined action of (a) its anteriorly biased configuration whichincreases accommodation amplitude and increased diopters ofaccommodation, and (b) increased power of its optic which increases theamount of accommodation produced by any given amount of accommodationmovement of the lens optic or, conversely, reduces the accommodationmovement of the optic required to produce any given amount ofaccommodation.

Lens 1050 comprises a one piece lens structure having a central optic1052 and flexibly hinged extended portions 1054 in the form of platehaptics extending generally radially from the optic. Each plate haptic1054 is longitudinally tapered in width and thickness so as to widen inwidth and increase in thickness toward its inner end. Each plate hapticincludes an inner plate portion 1056 which is integrally joined to anedge of the optic 1052 and inclines anteriorly relative to the optictoward its outer end, an outer plate portion 1058 joined to the outerend of the inner plate portion, and a V-groove 1060 entering at thejuncture of these plate portions so as to form at this juncture aflexible hinge 1062. The outer plate portion 1058 is pivotally movableat this hinge anteriorly and posteriorly relative to the inner plateportion 1056 and the optic 1052. The lens structure including its opticand haptic plate portions 1056, 1058 is molded or otherwise formed as aunitary lens structure from a lens material mentioned earlier and hasinserts 1064 fixed in the outer ends of the outer haptic plate portions1058. These inserts provide the lens extended portions or haptics 1054and may be utilized to reinforce the outer haptic plate portions 1058 ifnecessary.

Lens 1050 implanted in the capsular bag 20 of the eye with the ciliarymuscle of the eye paralyzed in its relaxed state and maintained in thisparalyzed state until the completion of fibrosis, all in the same manneras explained earlier. During this fibrosis, the lens optic 1052 is urgedposteriorly to its distant vision position shown in solid lines in FIG.57 and dashed lines in FIG. 58 wherein the posterior surface of theoptic presses rearwardly against the posterior capsule 24 of thecapsular bag and stretches this posterior capsule rearwardly. Theconfiguration which the lens 1050 assumes or occupies in this posteriordistant vision position is its posterior distant vision configuration.Ciliary muscle contraction during normal vision accommodation followingcompletion of fibrosis increases vitreous pressure and compresses thelenses radially or endwise to effect anterior accommodation movement ofthe lens optic 1052 in the same manner as explained earlier.

As mentioned above, lens 1050 is an anteriorly biased lens. In thisregard, it will be observed in FIGS. 57 and 58 that when the lensoccupies its posterior distant vision position, its haptic hinges 1062are located forwardly of a tip plane P passing through the outer tips ofthe lens haptics 1054 normal to the axis of the lens optic 1052 and theeye. Accordingly, compression of the lens by ciliary muscle contractionduring normal vision accommodation is effective to produce an anterioraccommodation force on the optic throughout its entire accommodationrange from its posterior distant vision through its mid-range position(solid lines in FIG. 58) to its anterior near vision position (phantomlines in FIG. 58). Compression of the lens by ciliary muscle contractionthereby aids the anterior vitreous pressure force on the opticthroughout its entire accommodation range and thereby increases theaccommodation amplitude and diop ters of accommodation of the lenses, asexplained earlier.

An important feature of lens 1050 is that its optic 1052 has increasedoptical or dioptic power which aids the anterior biased configuration ofthe lens to further increase accommodation amplitude and diopters ofaccommodation. To this end, the anterior face 1066 of the optic isrelatively flat or just lightly convex while the posterior face 1068 ofthe optic has a relatively steep convex curvature such that the optichas a generally planoconvex shape. This optic shape locates most or allof the optical power of the optic at the posterior side of the optic.Increasing the power of the lens optic in this way decreases thedistance through which the optic must move to produce any given amountof vision accommodation and, conversely, increases the amount of visionaccommodation produced by any given accommodation movement of the opticand thereby increases the maximum accommodation amplitude and dioptersof accommodation of the lens.

Increasing the power of an intraocular lens optic at the posterior sideof the optic, as in FIGS. 57-58, shifts the optical plane of the optic(i.e. plane from which the focal point of the optic originates)rearwardly toward the retina 16 of the eye. For example, the opticalplane P_(O) of lens optic 1052 is located at the approximate positionshown in FIG. 58 which is rearwardly of the optical plane position (notshown) of a symmetrical biconvex optic of the same center thicknessmeasured along the axis of the optic but having anterior and posteriorsurfaces of equal curvature. This rearward shift of the optical plane ofthe optic toward the retina must be compensated for by increasing thedioptic power of the optic in order to sharply focus incoming light rayson the retina. The required increase in the power of optic 1052 isaccomplished by appropriately shaping the steep convex curvature of theposterior surface 1068 of the optic.

FIG. 64 illustrates an embodiment of the invention which comprises acentral optic 1202 and extended portions or haptics 1204 which extendfrom opposite edge portions of the optic. The optic, in side view, (notshown) is preferably of the configuration shown in FIGS. 58 and 59 toprovide the operation and advantages earlier described relative to theembodiment of those figures.

The haptics or extended portions include plates 1206 which have innerends joined to the optic and with outer free ends, and laterallyextending flexible fixation fingers 1208 at the outer ends. Openings1209 are defined in the outer ends of each fixation finger for improvedfixation by fibrosis.

Haptic plates 1206 are longitudinally tapered to narrow in width in theoutward direction, and have a width throughout their length less thanthe diameter of the optic. The haptics and their outer ends are movableanteriorly and posteriorly relative to the optic. Hinges 1210 aredefined by grooves in the haptics which enter either anterior orposterior sides and extend across inner end portions of the hapticplates 1206.

The lens has a relatively flat unstressed configuration wherein haptics1204 and their hinges are disposed in a generally common plane. Theouter edges of the haptic plates and the fingers 1208 may preferably begenerally circularly curved about the axis of optic 1202. In theirnormal unstressed state, the fingers extend laterally outwardly fromopposite longitudinal edges of respective haptic plates. Whenunstressed, fingers 1208 are preferably bowed with slight inwardcurvature.

Deformation of the lens from the normal unstressed configuration byanterior or posterior deflection of the haptics produces elastic strainenergy forces in the hinges which urge the lens to its normal unstressedconfiguration.

FIG. 65A shows a modification of the embodiment of FIG. 65 wherein arecessed pocket 1214 is defined in a haptic portion for accommodating adrug, such as Atropine or a related drug, for paralyzing the ciliarymuscles over a time period, or another drug for some other purpose. Suchpocket may be provided in both haptics, although FIG. 65 shows only apartial view with only one haptic.

The embodiments of FIGS. 64 and 65 have the flexible fingers 1208 and1206 on inserts formed of a material different from that of the hapticplates, and preferably of a material which is not particularly inert,thus to effect better fibrosis formation about the fingers and theprotuberances 1209. Inert and relatively less inert materials are hereinearlier discussed. The haptic plates 1206 are preferably constructed ofresilient semi-rigid material.

FIGS. 66 and 67 illustrate somewhat related embodiments of theinvention.

The intraocular lens 1300 of FIG. 66 has an optic 1302, preferablyconfigurated, in side view, as shown in FIGS. 58 and 59 to provide theearlier described advantages and operation of the FIG. 59 embodiment ofthe invention. A plurality of relatively small extension portions orhaptic plates 1304 having hinges 1306 to facilitate posterior andanterior movement of the optic in response to ciliary muscle action. Thehinges 1336 are defined by grooves in the haptic plates and/or bygrooves 1306 a in the loops. Hinging action of the plates canalternatively be provided by forming the haptics of a flexible material.

Two pairs of the haptics extend oppositely from the optic, and a loop1310 extends between each pair of haptics, and is secured to thehaptics. An arm 1312 extends from an arcuate transverse portion of eachloop 1310 at an acute angle from the transverse portion. Each arm 1312has an end protuberance defining an opening 1314 for improved fixationand centration.

FIG. 67 illustrates a related embodiment 1350 having an optic 1352, andloops 1354 extending outwardly between pairs of spaced, radiallyextending small haptics or extension portions 1356. As with theembodiment of FIG. 66, hinging action may be provided by grooves 1356 inthe haptics or by grooves 1356 a in the loops. An arm 1358 extends fromeach loop at an acute angle thereto, and has a protuberance 1360defining a sizable opening at its end, as shown. Improved fibrosissecurement and centration, are provided, with or without the openingtherein, by the protuberance. The protuberances 1314 of FIG. 66 and 1360of FIG. 67, preferably with the openings therein, are important featuresin that they provide substantially improved retention and centration byfibrosis. The arms 1358 and their protuberances 1360, as well as theloops 1358, are preferably formed of a relatively non-inert material forimproved fibrosis thereabout.

Thus there has been shown and described a novel accommodatingintraocular lens which fulfills all the objects and advantages soughttherefor. Many changes, modifications, variations and other uses andapplications of the subject invention will, however, become apparent tothose skilled in the art after considering this specification togetherwith the accompanying drawings and claims. All such changes,modifications, variations and other uses and applications which do notdepart from the spirit and scope of the invention are deemed to becovered by the invention which is limited only by the claims whichfollow.

What is claimed is:
 1. An accommodating intraocular lens comprising: alens body having anterior and posterior sides, said lens body including:an optic; a first and second pair of haptic supports, each hapticsupport having an inner end adjacent said optic and an outer endextending from said optic; at least one loop haptic extending betweeneach haptic support of said first pair of haptic supports and at leastone loop haptic extending between each haptic support of said secondpair of haptic supports, said loop haptics having outer portionsextending from said haptic supports; and wherein, said lens body isadapted to be disposed in a natural capsular bag of the eye and isoperable to move the optic posteriorly and anteriorly relative to saidloop haptic outer portions in response to forces imparted by ciliarymuscle relaxation and constriction, respectively.
 2. The accommodatingintraocular lens as claimed in claim 1, further including at least onearm having an inner end connected to said loop haptic and an outer endextending from said loop haptic.
 3. The accommodating intraocular lensas claimed in claim 2, wherein said arm has an enlarged outer end. 4.The accommodating intraocular lens as claimed in claim 3, wherein saidenlarged outer end of said arm has an opening therethrough.
 5. Theaccommodating intraocular lens as claimed in claim 3, wherein saidenlarged outer end of said arm is disc shaped.
 6. The accommodatingintraocular lens as claimed in claim 3, wherein said enlarged outer endof said arm is formed from a biologically inert material selected fromthe group consisting of PMMA, Acrylic, Prolene, and Polyimide.
 7. Theaccommodating intraocular lens as claimed in claim 2, wherein at least aportion of said arm is formed from a biologically inert materialselected from the group consisting of PMMA, Acrylic, Prolene, andPolyimide.
 8. The accommodating intraocular lens as claimed in claim 2,wherein at least a portion of said arm is formed from a biologicallyinert material selected from the group consisting of Silicone, Polyhemaand HEMA.
 9. The accommodating intraocular lens claimed in claim 2,wherein said arm extends from said loop haptic at an acute anglethereto.
 10. The accommodating intraocular lens as claimed in claim 1,wherein said haptic supports include a hinge and about which the opticmoves posteriorly and anteriorly in response to forces imparted byciliary muscle relaxation and constriction.
 11. The accommodatingintraocular lens as claimed in claim 10, wherein said loop haptics haveat least one hinge and about which the optic moves posteriorly andanteriorly in response to forces imparted by ciliary muscle relaxationand constriction.
 12. The accommodating intraocular lens as claimed inclaim 10, wherein said haptic support hinge is a groove across ananterior surface of said haptic support.
 13. The accommodatingintraocular lens as claimed in claim 1, wherein said loop haptics haveat least one hinge and about which the optic moves posteriorly andanteriorly in response to forces imparted by ciliary muscle relaxationand constriction.
 14. The accommodating intraocular lens as claimed inclaim 13, wherein said loop haptic hinge is a groove across an anteriorsurface of said loop haptic.
 15. The accommodating intraocular lens asclaimed in claim 1, wherein said haptic supports are formed from aflexible material.
 16. The accommodating intraocular lens as claimed inclaim 15, wherein said flexible material is silicone.
 17. Theaccommodating intraocular lens as claimed in claim 15, wherein saidflexible material is a hydrogel.
 18. The accommodating intraocular lensas claimed in claim 1, wherein at least a portion of said loop haptic isformed from a biologically inert material selected from the groupconsisting of PMMA, Acrylic, Prolene, and Polyimide.
 19. Theaccommodating intraocular lens as claimed in claim 1, wherein at least aportion of said loop haptic is formed from a biologically inert materialselected from the group consisting of Silicone, Polyhema and HEMA. 20.The accommodating intraocular lens as claimed in claim 1, wherein saidhaptic supports are equally spaced about said optic.
 21. Theaccommodating intraocular lens as claimed in claim 1, wherein saidhaptic supports comprising said first pair of haptic supports extendfrom said optic parallel to each other, and said haptic supportscomprising said second pair of haptic supports extend from said opticparallel to each other.
 22. An accommodating intraocular lenscomprising: a lens body having anterior and posterior sides, said lensbody including: an optic; a first and second pair of haptic supports,each haptic support having an inner end adjacent said optic and an outerend extending from said optic; at least one loop haptic extendingbetween each haptic support of said first pair of haptic supports and atleast one loop haptic extending between each haptic support of saidsecond pair of haptic supports, said loop haptics having outer portionsextending from said haptic supports; and one or more hinges adjacent atleast one of said haptic supports and about which the optic movesposteriorly and anteriorly in response to forces imparted by ciliarymuscle relaxation and constriction, respectively; and wherein, said lensbody is adapted to be disposed in a natural capsular bag of the eye andis operable to move the optic posteriorly and anteriorly relative tosaid loop haptic outer portions in response to forces imparted byciliary muscle relaxation and constriction, respectively.
 23. Theaccommodating intraocular lens claimed in claim 22, wherein at least oneof said loop haptics further includes a hinge and about which the opticmoves posteriorly and anteriorly in response to forces imparted byciliary muscle relaxation and constriction, respectively.
 24. Theaccommodating intraocular lens claimed in claim 23, further including atleast one arm having an inner end connected to said loop haptic and anouter end extending from said loop haptic.
 25. The accommodatingintraocular lens claimed in claim 22, further including at least one armhaving an inner end connected to said loop haptic and an outer endextending from said loop haptic.
 26. An accommodating intraocular lenscomprising: a lens body having anterior and posterior sides, said lensbody including: an optic; a first and second pair of flexible hapticsupports, each flexible haptic support having an inner end adjacent saidoptic and an outer end extending from said optic; at least one loophaptic extending between each flexible haptic support of said first pairof haptic supports and at least one loop haptic extending between eachflexible haptic support of said second pair of haptic supports, saidloop haptics having outer portions extending from said haptic supports;and at least one arm having an inner end connected to said loop hapticand an outer end extending from said loop haptic; and wherein, said lensbody is adapted to be disposed in a natural capsular bag of the eye andis operable to move the optic posteriorly and anteriorly relative tosaid loop haptic outer portions in response to forces imparted byciliary muscle relaxation and constriction, respectively.
 27. Anaccommodating intraocular lens comprising: a lens body having anteriorand posterior sides, said lens body including: an optic; at least twoloop haptics having first and second ends connected to said optic, saidloop haptics having outer portions extending outwardly from said opticto fixate said lens body in a natural capsular bag; at least one armhaving an inner end connected to said loop haptic outer portion and anouter end extending from said loop haptic outer portion; and wherein,said lens body is adapted to be disposed in a natural capsular bag ofthe eye and is operable to move the optic posteriorly and anteriorlyrelative to said loop haptic outer portions in response to forcesimparted by ciliary muscle relaxation and constriction, respectively.28. The accommodating intraocular lens as claimed in claim 27, furtherincluding at least two pairs of haptic supports on opposite sides ofsaid optic, each haptic support has an inner end adjacent said optic andan outer end projecting from said optic, each pair of haptic outer endsis interconnected by at least one of said loop haptics, wherein saidloop haptic outer portions extend outwardly from said optic to fixatesaid lens body in a natural capsular bag.
 29. The accommodatingintraocular lens as claimed in claim 28, further including at least onehinge adjacent said haptic supports and about which the optic movesposteriorly and anteriorly in response to forces imparted by ciliarymuscle relaxation and constriction.
 30. The accommodating intraocularlens as claimed in claim 27, wherein said loop haptics include a hingeand about which the optic moves posteriorly and anteriorly in responseto forces imparted by ciliary muscle relaxation and constriction. 31.The accommodating intraocular lens as claimed in claim 30, wherein saidloop haptic hinge is a groove across an anterior surface of said loophaptic.
 32. The accommodating intraocular lens as claimed in claim 27,wherein said arm extends from said loop haptic outer portion at an acuteangle thereto.
 33. The accommodating intraocular lens as claimed inclaim 27, wherein said loop haptic outer portion is arcuate shaped. 34.The accommodating intraocular lens as claimed in claim 27, wherein saidarm has an enlarged outer end.
 35. The accommodating intraocular lens asclaimed in claim 34, wherein said enlarged outer end of said arm has anopening therethrough.
 36. The accommodating intraocular lens as claimedin claim 34, wherein said enlarged outer end of said arm is disc shaped.